Trial Outcomes & Findings for Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer (NCT NCT00108745)

NCT ID: NCT00108745

Last Updated: 2021-09-30

Results Overview

Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact.

• Recruitment status: UNKNOWN
• Study phase: PHASE3
• Target enrollment: 1157 participants
• Primary outcome timeframe: All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next five years.
• Results posted on: 2021-09-30

Participant Flow

Participant milestones

Measure	Arm I (Paclitaxel Poliglumex) Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Paclitaxel) Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (Observation) Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Overall Study STARTED	387	384	386
Overall Study COMPLETED	353	349	349
Overall Study NOT COMPLETED	34	35	37

Reasons for withdrawal

Measure	Arm I (Paclitaxel Poliglumex) Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Paclitaxel) Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (Observation) Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Overall Study Withdrawal by Subject	19	12	12
Overall Study Never Treated	8	10	12
Overall Study Ineligible	7	13	13

Baseline Characteristics

Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer

Baseline characteristics by cohort

Measure	Arm I (Paclitaxel Poliglumex) n=387 Participants Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Paclitaxel) n=384 Participants Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (Observation) n=386 Participants Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies	Total n=1157 Participants Total of all reporting groups
Age, Continuous	59.02 years STANDARD_DEVIATION 10.89 • n=5 Participants	58.80 years STANDARD_DEVIATION 10.42 • n=7 Participants	59.07 years STANDARD_DEVIATION 9.68 • n=5 Participants	58.96 years STANDARD_DEVIATION 10.34 • n=4 Participants
Age, Customized < 40 years	21 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	45 Participants n=4 Participants
Age, Customized 40 - 49 years	54 Participants n=5 Participants	71 Participants n=7 Participants	57 Participants n=5 Participants	182 Participants n=4 Participants
Age, Customized 50 - 59 years	115 Participants n=5 Participants	114 Participants n=7 Participants	138 Participants n=5 Participants	367 Participants n=4 Participants
Age, Customized 60 - 69 years	137 Participants n=5 Participants	132 Participants n=7 Participants	126 Participants n=5 Participants	395 Participants n=4 Participants
Age, Customized 70 - 79 years	56 Participants n=5 Participants	46 Participants n=7 Participants	49 Participants n=5 Participants	151 Participants n=4 Participants
Age, Customized >= 80 years	4 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Female	387 Participants n=5 Participants	384 Participants n=7 Participants	386 Participants n=5 Participants	1157 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	25 Participants n=7 Participants	16 Participants n=5 Participants	59 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	341 Participants n=5 Participants	338 Participants n=7 Participants	346 Participants n=5 Participants	1025 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	28 Participants n=5 Participants	21 Participants n=7 Participants	24 Participants n=5 Participants	73 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants	51 Participants n=4 Participants
Race (NIH/OMB) White	353 Participants n=5 Participants	352 Participants n=7 Participants	355 Participants n=5 Participants	1060 Participants n=4 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
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants

PRIMARY outcome

Timeframe: All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next five years.

Population: All randomized

Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact.

Outcome measures

Measure	Arm I (Paclitaxel Poliglumex) n=387 Participants Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Paclitaxel) n=384 Participants Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (Observation) n=386 Participants Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Overall Survival	60.0 Months Interval 51.7 to 68.6	56.8 Months Interval 47.3 to 65.9	58.3 Months Interval 51.9 to 72.5

SECONDARY outcome

Timeframe: Progression was assessed every 8 weeks for the first 15 months, then every 3 months, up to 14.2 years.

Population: All randomized

Progression free survival (PFS) was defined as the number of months between study enrollment and the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause. Patients who were alive without progression at the time of analysis were censored on the date of the last tumor assessment.

Outcome measures

Measure	Arm I (Paclitaxel Poliglumex) n=387 Participants Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Paclitaxel) n=384 Participants Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (Observation) n=386 Participants Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Progression-free Survival	16.3 Months Interval 14.4 to 18.9	18.9 Months Interval 17.0 to 21.8	13.4 Months Interval 11.2 to 15.7

SECONDARY outcome

Timeframe: Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks.

Population: Treated with randomized therapy

Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy among adverse event terms with at least 4 patients reporting.

Outcome measures

Measure	Arm I (Paclitaxel Poliglumex) n=379 Participants Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Paclitaxel) n=374 Participants Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (Observation) n=386 Participants Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Fatigue	6 participants	13 participants	1 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Hemoglobin	8 participants	2 participants	0 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Hyperglycemia	5 participants	6 participants	1 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Hypertension	2 participants	4 participants	5 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Allergic Reaction / Hypersensitivity	4 participants	0 participants	0 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Dehydration	4 participants	1 participants	1 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Diarrhea	7 participants	3 participants	2 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Dyspnea	2 participants	4 participants	2 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Hypokalemia	9 participants	2 participants	0 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Leukocytes	36 participants	17 participants	1 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Nausea	7 participants	3 participants	4 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Neuropathy-Motor	3 participants	8 participants	1 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Neutrophils	82 participants	62 participants	2 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Obstruction, GI - Small Bowel Nos	5 participants	6 participants	9 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Pain: Abdominal Pain Nos	12 participants	5 participants	5 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Pain: Back	7 participants	4 participants	1 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Pain: Extremity-Limb	1 participants	7 participants	0 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Pain: Head/Headache	4 participants	2 participants	0 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Pain: Joint	5 participants	3 participants	1 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Thrombosis / Thrombus / Embolism	5 participants	4 participants	2 participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 Vomiting	8 participants	6 participants	3 participants

SECONDARY outcome

Timeframe: 1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment

Population: Provided baseline and \>= 1 follow-up assessment

Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-En TOI is a scale for assessing general QOL of ovarian cancer patients. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL.

Outcome measures

Measure	Arm I (Paclitaxel Poliglumex) n=374 Participants Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Paclitaxel) n=366 Participants Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (Observation) n=373 Participants Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Patient-Reported Quality of Life (QOL) Baseline	78.2 score on a scale Standard Error 0.6	77.3 score on a scale Standard Error 0.7	77.4 score on a scale Standard Error 0.7
Patient-Reported Quality of Life (QOL) Prior to cycle 3	78.8 score on a scale Standard Error 0.7	76.9 score on a scale Standard Error 0.7	80.0 score on a scale Standard Error 0.7
Patient-Reported Quality of Life (QOL) Prior to cycle 5	79.3 score on a scale Standard Error 0.7	77.6 score on a scale Standard Error 0.7	80.8 score on a scale Standard Error 0.7
Patient-Reported Quality of Life (QOL) Prior to cycle 7	80.0 score on a scale Standard Error 0.7	77.5 score on a scale Standard Error 0.8	79.5 score on a scale Standard Error 0.8
Patient-Reported Quality of Life (QOL) Prior to cycle 12	78.3 score on a scale Standard Error 0.8	76.8 score on a scale Standard Error 0.8	79.2 score on a scale Standard Error 0.8
Patient-Reported Quality of Life (QOL) 12 months post treatment	78.8 score on a scale Standard Error 0.9	76.0 score on a scale Standard Error 0.9	77.4 score on a scale Standard Error 0.9

SECONDARY outcome

Timeframe: 1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment

Population: Provided baseline and \>= 1 follow-up assessment

Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms.

Outcome measures

Measure	Arm I (Paclitaxel Poliglumex) n=374 Participants Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Paclitaxel) n=366 Participants Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (Observation) n=373 Participants Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Patient-Reported Peripheral Neuropathy Symptoms Baseline	11.4 score on a scale Standard Error 0.2	11.7 score on a scale Standard Error 0.2	11.8 score on a scale Standard Error 0.2
Patient-Reported Peripheral Neuropathy Symptoms Prior to cycle 3	9.6 score on a scale Standard Error 0.2	10.6 score on a scale Standard Error 0.2	11.5 score on a scale Standard Error 0.2
Patient-Reported Peripheral Neuropathy Symptoms Prior to cycle 5	9.5 score on a scale Standard Error 0.2	11.3 score on a scale Standard Error 0.2	11.9 score on a scale Standard Error 0.2
Patient-Reported Peripheral Neuropathy Symptoms Prior to cycle 7	9.8 score on a scale Standard Error 0.2	11.3 score on a scale Standard Error 0.2	12.4 score on a scale Standard Error 0.2
Patient-Reported Peripheral Neuropathy Symptoms Prior to cycle 12	9.4 score on a scale Standard Error 0.2	11.6 score on a scale Standard Error 0.2	12.2 score on a scale Standard Error 0.2
Patient-Reported Peripheral Neuropathy Symptoms 12 months post treatment	10.7 score on a scale Standard Error 0.3	11.7 score on a scale Standard Error 0.3	12.4 score on a scale Standard Error 0.2

Adverse Events

Arm I (Paclitaxel Poliglumex)

Serious events: 50 serious events

Other events: 378 other events

Deaths: 235 deaths

Arm II (Paclitaxel)

Serious events: 39 serious events

Other events: 372 other events

Deaths: 242 deaths

Arm III (Observation)

Serious events: 1 serious events

Other events: 312 other events

Deaths: 230 deaths

Serious adverse events

Measure	Arm I (Paclitaxel Poliglumex) n=379 participants at risk Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Paclitaxel) n=374 participants at risk Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (Observation) n=386 participants at risk Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Immune system disorders Allergic Reaction/Hypersensitivity	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Immune system disorders Rhinitis	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Ear and labyrinth disorders Tinnitus	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Neutrophils	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Hemoglobin	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders S/N Arrhythmia: Atrial Fibrillation	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders Cardiac General - Other	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders Pericardial Effusion	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders Pericarditis	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Weight Gain	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Fever	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Insomnia	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Nail Changes	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Wound Complication, Non-Infectious	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Obstruction, Gi - Stomach	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Obstruction, Gi - Ileum	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Obstruction, Gi - Colon	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Gastritis	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Ileus	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	1.1% 4/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Colitis	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Vomiting	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Dehydration	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Diarrhea	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Hepatobiliary disorders Cholecystitis	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Blood	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Wound	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Febrile Neutropenia	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Lung (Pneumonia)	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Colitis, Infectious (Eg.C. Difficile)	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Pelvis Nos	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Sinus	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Bladder (Urinary)	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Wound	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Kidney	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hyponatremia	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Musculoskeletal and connective tissue disorders Fracture	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Syncope	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Encephalopathy	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Mood Alteration - Depression	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Mood Alteration - Anxiety	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Cns Ischemia	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Dizziness	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Neuropathy-Sensory	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Neuropathy-Motor	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Eye disorders Retinal Detachment	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Eye disorders Dry Eye	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain - Other	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Chest Wall	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Head/Headache	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Back	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Bone	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Stomach	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Abdominal Pain Nos	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Respiratory, thoracic and mediastinal disorders Pulmonary: Other	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Respiratory, thoracic and mediastinal disorders Dyspnea	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 2nd Mal: Poss. Related To Cancer Rx	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Syndromes - Other	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Thrombosis/Thrombus/Embolism	1.1% 4/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).

Other adverse events

Measure	Arm I (Paclitaxel Poliglumex) n=379 participants at risk Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Paclitaxel) n=374 participants at risk Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (Observation) n=386 participants at risk Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Immune system disorders Allergy/Immunology - Other	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Immune system disorders Allergic Reaction/Hypersensitivity	6.9% 26/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.2% 12/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.0% 4/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Immune system disorders Rhinitis	5.0% 19/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	8.3% 31/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	4.9% 19/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Immune system disorders Autoimmune Reaction	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Ear and labyrinth disorders Otitis Middle Ear	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Ear and labyrinth disorders Auditory/Ear - Other	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Ear and labyrinth disorders Otitis External Ear	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Ear and labyrinth disorders Hearing (Without Monitoring Program)	1.3% 5/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.1% 4/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Ear and labyrinth disorders Tinnitus	6.1% 23/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	7.8% 29/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.6% 14/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Ear and labyrinth disorders Hearing (Monitoring Program)	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Neutrophils	50.1% 190/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	57.0% 213/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	7.3% 28/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Platelets	30.3% 115/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	17.4% 65/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.6% 14/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Blood/Bone Marrow - Other	1.3% 5/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Bone Marrow Cellularity	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Leukocytes	60.4% 229/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	61.8% 231/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	11.4% 44/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Lymphopenia	1.3% 5/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.7% 10/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Hemoglobin	71.2% 270/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	75.7% 283/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	21.5% 83/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders S/N Arrhythmia: Atrial Fibrillation	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders Palpitations	2.1% 8/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.7% 10/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.0% 4/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders Cardiac Arrhythmia - Other	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders Ventricular Arrhythmia - Tachycardia	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders S/N Arrhythmia: Sinus Tachycardia	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders Vasovagal Episode	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders S/N Arrhythmia: Sinus Bradycardia	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders Hypertension	7.4% 28/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	7.5% 28/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	6.0% 23/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders Valvular Heart Disease	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders Left Venticular Diastolic Dysfunction	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders Lt Ventricular Systolic Dysfunction	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders Cardiac General - Other	1.3% 5/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Cardiac disorders Hypotension	1.1% 4/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.1% 4/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Inr	1.6% 6/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.1% 4/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Coagulopathy - Other	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Ptt	1.8% 7/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.0% 4/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Constitutional Symptoms - Other	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Sweating	1.3% 5/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.7% 14/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.8% 7/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Weight Gain	11.9% 45/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	12.3% 46/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	7.0% 27/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Fever	7.1% 27/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	6.7% 25/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.1% 8/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Weight Loss	1.6% 6/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.9% 7/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.6% 10/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Hypothermia	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Rigors/Chills	2.4% 9/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.2% 12/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Fatigue	67.0% 254/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	74.1% 277/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	37.0% 143/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Insomnia	18.2% 69/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	21.7% 81/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	13.0% 50/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Nail Changes	3.2% 12/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	5.1% 19/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Photosensitivity	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Injection Site Reaction	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Hair Loss/Alopecia (Scalp Or Body)	35.6% 135/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	63.9% 239/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	19.7% 76/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Induration	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Wound Complication, Non-Infectious	1.1% 4/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Bruising	3.4% 13/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.5% 13/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.6% 10/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Acne	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Rash	13.2% 50/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	12.3% 46/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	5.2% 20/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Striae	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Dry Skin	2.4% 9/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.9% 11/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Pruritus	4.7% 18/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	5.6% 21/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.1% 12/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Burn	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Urticaria	1.1% 4/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Flushing	5.8% 22/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	5.3% 20/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	2.4% 9/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.2% 12/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.8% 7/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Hyperpigmentation	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Skin and subcutaneous tissue disorders Ulceration	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Endocrine disorders Hot Flashes	14.0% 53/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	13.9% 52/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	11.1% 43/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Endocrine disorders Diabetes	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Endocrine disorders Adh Secrection Abnormality	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Endocrine disorders Hypoparathyroidism	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Endocrine disorders Hyperthyroidism	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Endocrine disorders Endocrine - Other	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Endocrine disorders Hypothyroidism	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Proctitis	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Flatulence	1.8% 7/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.9% 11/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.4% 13/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Ulcer,gi - Esophagus	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Dental: Periodontal	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Obstruction, Gi - Colon	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Gastritis	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Esophagitis	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Hemorrhoids	1.3% 5/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.1% 4/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Heartburn	9.2% 35/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	8.6% 32/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	4.9% 19/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Dental: Teeth	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.9% 7/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Mucositis (Functional/Sympt) - Pharynx	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Ascites	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Ileus	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Dental: Teeth Development	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Dysphagia	1.3% 5/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.1% 4/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Distention	6.6% 25/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	6.1% 23/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	8.8% 34/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Taste Alteration	2.9% 11/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	5.1% 19/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Incontinence, Anal	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Dry Mouth	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.9% 7/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Mucositis (Functional/Sympt) - Oral Cavity	1.6% 6/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	4.0% 15/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.8% 11/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Obstruction, Gi - Jejunum	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Mucositis (Clinical Exam) - Oral Cavity	4.0% 15/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	5.6% 21/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Vomiting	14.0% 53/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	11.0% 41/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	9.3% 36/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Anorexia	10.8% 41/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	12.3% 46/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	5.4% 21/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Dehydration	1.3% 5/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Constipation	41.2% 156/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	42.2% 158/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	22.8% 88/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Nausea	38.3% 145/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	36.6% 137/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	16.3% 63/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Gastrointestinal - Other	2.4% 9/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.7% 10/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.3% 9/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Diarrhea	23.2% 88/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	25.9% 97/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	14.5% 56/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Gastrointestinal disorders Prolapse Of Stoma, Gi	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Hemorrhage, Gu - Stoma	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Hemorrhage, Gu - Vagina	2.4% 9/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Hemorrhage, Gu - Urethra	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Hemorrhage, Gi - Rectum	1.6% 6/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Hemorrhage, Gi - Upper Gi Nos	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Hemorrhage/Pulmonary - Nose	5.0% 19/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.1% 8/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Hematoma	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Hemorrhage, Gi - Anus	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Hemorrhage, Gi - Esophagus	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Hemorrhage, Gi - Lower Gi Nos	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Hemorrhage, Gi - Oral Cavity	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Hemorrhage, Gu - Bladder	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Petechiae	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Hemorrhage/Bleeding - Other	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Hepatobiliary disorders Hepatobiliary/Pancreas - Other	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Hepatobiliary disorders Cholecystitis	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Hepatobiliary disorders Liver Dysfunction	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis)	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Vulva	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos	3.4% 13/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.2% 12/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Nose	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Gr 3 Or 4 Anc: Lip/Perioral	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Eye Nos	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Peristomal	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Blood	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Wound	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Lip/Perioral	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Nerve-Peripheral	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Lung (Pneumonia)	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Sinus	1.1% 4/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Colon	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	3.4% 13/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	4.3% 16/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Ungual (Nails)	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Stomach	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Infection - Other	2.4% 9/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	4.3% 16/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.0% 4/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Nerve-Peripheral	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Vulva	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Vagina	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus	1.3% 5/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Upper Airway Nos	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Upper Aerodigestive	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Vagina	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.1% 4/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Sinus	1.6% 6/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Pharynx	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Bronchus	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Eye Nos	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Joint	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Lymphatic	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Urinary Tract Nos	1.8% 7/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.1% 8/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Bladder (Urinary)	1.1% 4/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.1% 4/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Wound	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Oral Cavity-Gums	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Dental-Tooth	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Appendix	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Anal/Perianal	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Abdomen Nos	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Skin (Cellulitis)	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.0% 4/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Peristomal	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: Middle Ear	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf Unknown Anc: External Ear	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Gr 3 Or 4 Anc: Pelvis Nos	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Gr 3 Or 4 Anc: Upper Airway Nos	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Gr 3 Or 4 Anc: Sinus	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Kidney	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Infections and infestations Inf W/Gr 3 Or 4 Anc: Catheter-Related	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Lymphatics - Other	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Lymphocele	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Edema: Viscera	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Edema: Trunk/Genital	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Edema: Limb	19.0% 72/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	18.7% 70/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	8.0% 31/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Edema: Head And Neck	1.3% 5/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.9% 7/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Blood and lymphatic system disorders Dermal Change	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Ast	18.2% 69/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	6.4% 24/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.1% 12/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Gfr	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.1% 4/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Metabolic/Laboratory - Other	3.2% 12/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.5% 13/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.0% 4/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Alkalosis	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Cholesterol,serum High	1.6% 6/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.0% 4/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Proteinuria	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hemoglobinuria	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Creatinine	3.7% 14/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	5.6% 21/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.8% 11/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hypoalbuminemia	2.9% 11/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.2% 12/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Alt	9.5% 36/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	7.2% 27/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.1% 8/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Alkaline Phosphatase	10.0% 38/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	8.6% 32/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	4.1% 16/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Bilirubin	1.6% 6/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.0% 4/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hypermagnesemia	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.1% 4/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hypophosphatemia	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hyponatremia	5.8% 22/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	4.0% 15/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.1% 8/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hyperuricemia	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hypertriglyceridemia	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.1% 4/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Bicarbonate, Serum-Low	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Amylase	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hypernatremia	1.3% 5/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.4% 9/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.0% 4/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hypocalcemia	4.0% 15/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.7% 10/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hyperkalemia	1.1% 4/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hyperglycemia	20.8% 79/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	17.9% 67/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	7.0% 27/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hypokalemia	8.7% 33/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	7.5% 28/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.4% 13/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hypoglycemia	2.6% 10/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.7% 14/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.3% 9/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hypercalcemia	3.4% 13/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.9% 11/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.3% 9/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Metabolism and nutrition disorders Hypomagnesemia	9.8% 37/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	7.8% 29/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.6% 10/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Musculoskeletal and connective tissue disorders Musculoskeletal/St: Other	2.6% 10/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.2% 12/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Musculoskeletal and connective tissue disorders Osteoporosis	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Musculoskeletal and connective tissue disorders Joint-Function	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Musculoskeletal and connective tissue disorders Joint Effusion	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Musculoskeletal and connective tissue disorders Fracture	1.1% 4/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.8% 7/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Musculoskeletal and connective tissue disorders Gait/Walking	1.6% 6/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Musculoskeletal and connective tissue disorders Arthritis	4.0% 15/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.5% 13/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.6% 14/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Musculoskeletal and connective tissue disorders Muscle Weakness - Whole Body/Generalized	2.6% 10/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	4.3% 16/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.8% 11/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Musculoskeletal and connective tissue disorders Muscle Weakness - Trunk	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Musculoskeletal and connective tissue disorders Muscle Weakness - Left-Sided	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Musculoskeletal and connective tissue disorders Muscle Weakness - Facial	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Musculoskeletal and connective tissue disorders Muscle Weakness - Extremity-Upper	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Musculoskeletal and connective tissue disorders Muscle Weakness - Extremity-Lower	1.6% 6/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.7% 10/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.3% 9/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Syncope	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Involuntary Movement	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.1% 4/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Psychosis	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Neurology - Other	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.1% 8/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Mental Status	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Mood Alteration - Depression	11.6% 44/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	16.6% 62/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	12.2% 47/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Mood Alteration - Anxiety	11.3% 43/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	14.2% 53/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	11.1% 43/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Mood Alteration - Agitation	1.6% 6/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.7% 10/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Tremor	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Speech Impairment	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Seizure	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Personality	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Irritability	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Somnolence	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Cognitive Disturbance	1.8% 7/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Ataxia	1.1% 4/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Confusion	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Memory Impairment	4.5% 17/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	9.9% 37/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.6% 14/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Dizziness	10.0% 38/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	11.2% 42/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	4.4% 17/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Neuropathy,cranial - Cn Viii Hearing/Balance	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Neuropathy,cranial - Cn V Motor-Jaw Muscles	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Neuropathy-Sensory	83.9% 318/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	78.6% 294/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	45.3% 175/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Nervous system disorders Neuropathy-Motor	8.7% 33/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	8.3% 31/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.9% 15/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Eye disorders Ocular/Visual - Other	1.1% 4/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.4% 9/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Eye disorders Nystagmus	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Eye disorders Watery Eye	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Eye disorders Glaucoma	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Eye disorders Dry Eye	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Eye disorders Ocular Surface Disease	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Eye disorders Cataract	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Eye disorders Photophobia	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Eye disorders Flashing Lights/Floaters	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Eye disorders Diplopia	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Eye disorders Blurred Vision	5.0% 19/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	8.0% 30/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.1% 12/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Eye disorders Eyelid Dysfunction	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain - Other	5.0% 19/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	6.4% 24/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	5.7% 22/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Urethra	2.4% 9/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Perineum	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Pelvis	5.3% 20/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.7% 14/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	4.7% 18/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Breast	1.8% 7/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Vagina	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.9% 7/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.8% 7/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Chest /Thorax Nos	5.5% 21/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	4.8% 18/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.8% 7/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Chest Wall	3.2% 12/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.1% 4/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Throat/Pharynx/Larynx	1.6% 6/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	4.8% 18/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Pleura	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Eye	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Head/Headache	16.4% 62/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	13.9% 52/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	5.7% 22/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Neck	1.6% 6/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.9% 7/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.8% 7/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Intestine	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Extremity-Limb	16.1% 61/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	20.3% 76/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	7.8% 30/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Buttock	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Back	13.7% 52/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	13.9% 52/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	12.4% 48/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Joint	28.0% 106/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	35.6% 133/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	21.0% 81/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Bone	5.5% 21/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	6.7% 25/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.3% 9/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Gallbladder	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Kidney	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Bladder	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Pain Nos	1.3% 5/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.9% 7/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Stomach	1.6% 6/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Rectum	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Oral Cavity	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Dental/Teeth/Peridontal	1.1% 4/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Abdominal Pain Nos	29.3% 111/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	27.3% 102/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	31.1% 120/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Scalp	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Oral - Gums	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Skin	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Lip	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Middle Ear	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: External Ear	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Cardiac/ Heart	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Face	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Liver	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Muscle	20.3% 77/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	27.3% 102/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	11.4% 44/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Anus	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Neuralgia	1.8% 7/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.4% 9/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Pain: Sinus	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Respiratory, thoracic and mediastinal disorders Pulmonary: Other	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Respiratory, thoracic and mediastinal disorders Airway Obstruction - Bronchus	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Respiratory, thoracic and mediastinal disorders Nasal/Paranasal Reactions	2.9% 11/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.5% 13/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Respiratory, thoracic and mediastinal disorders Voice Changes	1.6% 6/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Respiratory, thoracic and mediastinal disorders Hiccoughs	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Respiratory, thoracic and mediastinal disorders Cough	13.7% 52/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	20.1% 75/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	8.0% 31/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Respiratory, thoracic and mediastinal disorders Dyspnea	17.4% 66/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	19.3% 72/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	10.6% 41/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Renal and urinary disorders Renal/Genitourinary - Other	1.8% 7/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.1% 4/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Renal and urinary disorders Leak, Gu - Bladder	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Renal and urinary disorders Cystitis	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.0% 4/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Renal and urinary disorders Urinary Color Change	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Renal and urinary disorders Urinary Retention	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Renal and urinary disorders Obstruction, Gu - Ureter	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Renal and urinary disorders Incontinence, Urinary	4.2% 16/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	5.1% 19/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	3.4% 13/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Renal and urinary disorders Bladder Spasm	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.1% 4/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Renal and urinary disorders Urinary Frequency	4.0% 15/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	8.0% 30/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	6.2% 24/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 2nd Mal: Poss. Related To Cancer Rx	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Reproductive system and breast disorders Libido	1.3% 5/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Reproductive system and breast disorders Vaginal Dryness	2.9% 11/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.4% 9/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.1% 8/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Reproductive system and breast disorders Sexual/Reproductive Function: Other	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Reproductive system and breast disorders Vaginitis	0.79% 3/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.3% 5/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Reproductive system and breast disorders Vaginal Stenosis	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Reproductive system and breast disorders Vaginal Discharge	1.1% 4/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	2.4% 9/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.0% 4/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Surgical and medical procedures Intra-Op Injury: Abdomen Nos	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
General disorders Flu-Like Syndrome	1.6% 6/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	1.6% 6/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.78% 3/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Vascular - Other	0.26% 1/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Vein Injury - Extremity-Lower	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.27% 1/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Thrombosis/Embolism (Vascular Access-Related)	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.53% 2/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Thrombosis/Thrombus/Embolism	0.53% 2/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.80% 3/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.52% 2/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
Vascular disorders Phlebitis	0.00% 0/379 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.00% 0/374 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).	0.26% 1/386 • All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years. Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).

Additional Information

Christopher Purdy on behalf of Austin Miller PhD

NRG Oncology

Phone: (716) 845-1300

Email: purdyc@nrgoncology.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60