Trial Outcomes & Findings for Prevention of Serious Adverse Events Following Angiography (NCT NCT01467466)

Last Updated: 2025-11-05

Results Overview

Death will be based on medical record and/or vital status registry documentation Need for acute dialysis will be defined as the initiation of any modality of renal replacement (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) Persistent decline in kidney function will be defined as an increase in serum creatinine of at least 50% from the baseline value collected pre-angiography to the measurement taken 90 days following the angiography.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

5177 participants

Primary outcome timeframe

Within 90 days following angiography

Results posted on

2025-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	Saline & oral placebo IV isotonic saline and oral placebo drug capsule IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	Saline & oral N-acetylcysteine IV isotonic saline and oral N-acetylcysteine (NAC) drug capsule IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	Bicarbonate & oral placebo IV isotonic bicarbonate and oral placebo drug capsule IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	Bicarbonate & oral N-acetylcysteine IV isotonic bicarbonate and oral N-acetylcysteine drug capsule IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.
Overall Study STARTED	1300	1292	1294	1291
Overall Study COMPLETED	1191	1188	1190	1203
Overall Study NOT COMPLETED	109	104	104	88

Reasons for withdrawal

Reasons for withdrawal
Measure	Saline & oral placebo IV isotonic saline and oral placebo drug capsule IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	Saline & oral N-acetylcysteine IV isotonic saline and oral N-acetylcysteine (NAC) drug capsule IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	Bicarbonate & oral placebo IV isotonic bicarbonate and oral placebo drug capsule IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	Bicarbonate & oral N-acetylcysteine IV isotonic bicarbonate and oral N-acetylcysteine drug capsule IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.
Overall Study Withdrawal by Subject	15	18	13	11
Overall Study Revoked Consent Prior To Procedure	10	9	15	5
Overall Study Procedure Cancelled	46	45	25	29
Overall Study No Endpoint Blood Draw	38	32	51	43

Baseline Characteristics

Prevention of Serious Adverse Events Following Angiography

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saline & oral placebo n=1244 Participants IV isotonic saline and oral placebo drug capsule IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	Saline & oral N-acetylcysteine n=1238 Participants IV isotonic saline and oral N-acetylcysteine drug capsule IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	Bicarbonate & oral placebo n=1254 Participants IV isotonic bicarbonate and oral placebo drug capsule IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	Bicarbonate & oral N-acetylcysteine n=1257 Participants IV isotonic bicarbonate and oral N-acetylcysteine drug capsule IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	Total n=4993 Participants Total of all reporting groups
Race/Ethnicity, Customized Ethnicity · Cuban	0 Participants n=15 Participants	1 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	1 Participants n=8 Participants
Age, Continuous	69.6 Years STANDARD_DEVIATION 8.4 • n=15 Participants	69.8 Years STANDARD_DEVIATION 8.3 • n=161 Participants	69.6 Years STANDARD_DEVIATION 8.3 • n=100 Participants	70.2 Years STANDARD_DEVIATION 8.0 • n=3 Participants	69.8 Years STANDARD_DEVIATION 8.2 • n=8 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	11 Participants n=15 Participants	7 Participants n=161 Participants	9 Participants n=100 Participants	8 Participants n=3 Participants	35 Participants n=8 Participants
Race/Ethnicity, Customized Race · Asian	64 Participants n=15 Participants	58 Participants n=161 Participants	69 Participants n=100 Participants	65 Participants n=3 Participants	256 Participants n=8 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	19 Participants n=15 Participants	10 Participants n=161 Participants	16 Participants n=100 Participants	17 Participants n=3 Participants	62 Participants n=8 Participants
Race/Ethnicity, Customized Ethnicity · Mexican, Mexican American, or Chicano	17 Participants n=15 Participants	9 Participants n=161 Participants	27 Participants n=100 Participants	20 Participants n=3 Participants	73 Participants n=8 Participants
Race/Ethnicity, Customized Ethnicity · Puerto Rican	5 Participants n=15 Participants	3 Participants n=161 Participants	1 Participants n=100 Participants	3 Participants n=3 Participants	12 Participants n=8 Participants
Race/Ethnicity, Customized Ethnicity · Other Spanish Hispanic, or Latino	21 Participants n=15 Participants	16 Participants n=161 Participants	31 Participants n=100 Participants	27 Participants n=3 Participants	95 Participants n=8 Participants
Race/Ethnicity, Customized Ethnicity · Chose Not to Answer	11 Participants n=15 Participants	11 Participants n=161 Participants	16 Participants n=100 Participants	10 Participants n=3 Participants	48 Participants n=8 Participants
Region of Enrollment New Zealand	45 Participants n=15 Participants	45 Participants n=161 Participants	44 Participants n=100 Participants	45 Participants n=3 Participants	179 Participants n=8 Participants
Region of Enrollment United States	1068 Participants n=15 Participants	1054 Participants n=161 Participants	1068 Participants n=100 Participants	1077 Participants n=3 Participants	4267 Participants n=8 Participants
Region of Enrollment Malaysia	56 Participants n=15 Participants	57 Participants n=161 Participants	59 Participants n=100 Participants	58 Participants n=3 Participants	230 Participants n=8 Participants
Sex/Gender, Customized Sex · Unknown/Not Stated	1 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	1 Participants n=8 Participants
Sex/Gender, Customized Sex · Female	86 Participants n=15 Participants	75 Participants n=161 Participants	87 Participants n=100 Participants	73 Participants n=3 Participants	321 Participants n=8 Participants
Sex/Gender, Customized Sex · Male	1157 Participants n=15 Participants	1163 Participants n=161 Participants	1167 Participants n=100 Participants	1184 Participants n=3 Participants	4671 Participants n=8 Participants
Race/Ethnicity, Customized Race · Black or AFrican American	141 Participants n=15 Participants	158 Participants n=161 Participants	150 Participants n=100 Participants	121 Participants n=3 Participants	570 Participants n=8 Participants
Race/Ethnicity, Customized Race · White	971 Participants n=15 Participants	967 Participants n=161 Participants	962 Participants n=100 Participants	993 Participants n=3 Participants	3893 Participants n=8 Participants
Race/Ethnicity, Customized Race · Indigenous Austrailian	1 Participants n=15 Participants	1 Participants n=161 Participants	0 Participants n=100 Participants	2 Participants n=3 Participants	4 Participants n=8 Participants
Race/Ethnicity, Customized Race · More than one race	31 Participants n=15 Participants	37 Participants n=161 Participants	43 Participants n=100 Participants	50 Participants n=3 Participants	161 Participants n=8 Participants
Race/Ethnicity, Customized Race · Unknown or Not Reported	6 Participants n=15 Participants	0 Participants n=161 Participants	5 Participants n=100 Participants	1 Participants n=3 Participants	12 Participants n=8 Participants
Race/Ethnicity, Customized Ethnicity · Not Spanish, Hispanic or Latino	1190 Participants n=15 Participants	1198 Participants n=161 Participants	1179 Participants n=100 Participants	1197 Participants n=3 Participants	4764 Participants n=8 Participants
Region of Enrollment Australia	75 Participants n=15 Participants	82 Participants n=161 Participants	83 Participants n=100 Participants	77 Participants n=3 Participants	317 Participants n=8 Participants

PRIMARY outcome

Timeframe: Within 90 days following angiography

Outcome measures

Outcome measures
Measure	Sodium Bicarbonate n=2393 Participants A grouping of participants receiving Sodium Bicarbonate.	Saline n=2379 Participants A grouping of participants receiving Saline.
Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride.	111 Participants	116 Participants

PRIMARY outcome

Timeframe: Within 90 days following angiography

Outcome measures

Outcome measures
Measure	Sodium Bicarbonate n=2391 Participants A grouping of participants receiving Sodium Bicarbonate.	Saline n=2381 Participants A grouping of participants receiving Saline.
Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Oral N-Acetylcysteine With Oral Placebo.	115 Participants	112 Participants

Adverse Events

IV isotonic saline & oral placebo

Serious events: 941 serious events

Other events: 61 other events

Deaths: 28 deaths

IV isotonic saline & oral N-acetylcysteine

Serious events: 1040 serious events

Other events: 158 other events

Deaths: 40 deaths

IV isotonic bicarbonate & oral placebo

Serious events: 1083 serious events

Other events: 83 other events

Deaths: 33 deaths

IV isotonic bicarbonate & oral N-acetylcysteine

Serious events: 941 serious events

Other events: 170 other events

Deaths: 28 deaths

Serious adverse events

Other adverse events

Additional Information

Christopher Donnelly, Chief of Data Management

MAVERIC, VA Boston

Phone: 857-364-2332

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee "Cooperative Studies Program (CSP) retains ownership rights to all data collected in a CSP study…policies for data analysis and dissemination of results apply to all members of the Study Group (Study Chair (SC), Site Investigators (SIs), Study Biostatistician or Epidemiologist, etc.). If a SC or SI misuses study data, submits unauthorized manuscripts for publication, or releases results prior to the lifting of any embargoes or agreed upon time...administrative actions may be taken…"
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	IV isotonic saline & oral placebo n=1300 participants at risk IV isotonic saline and oral placebo drug capsule IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	IV isotonic saline & oral N-acetylcysteine n=1292 participants at risk IV isotonic saline and oral N-acetylcysteine drug capsule IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	IV isotonic bicarbonate & oral placebo n=1294 participants at risk IV isotonic bicarbonate and oral placebo drug capsule IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	IV isotonic bicarbonate & oral N-acetylcysteine n=1291 participants at risk IV isotonic bicarbonate and oral N-acetylcysteine drug capsule IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.
Cardiac disorders Coronary artery occlusion	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.23% 3/1294 • Number of events 3 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1291 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Coronary artery perforation	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Coronary artery stenosis	0.62% 8/1300 • Number of events 8 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.31% 4/1292 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.54% 7/1294 • Number of events 7 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.31% 4/1291 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Bradycardia	0.38% 5/1300 • Number of events 5 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.46% 6/1292 • Number of events 6 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.31% 4/1294 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.31% 4/1291 • Number of events 5 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Bundle branch block left	0.15% 2/1300 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Cardiac arrest	0.31% 4/1300 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.31% 4/1292 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.23% 3/1294 • Number of events 3 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.46% 6/1291 • Number of events 6 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Cardiac failure acute	0.31% 4/1300 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.85% 11/1292 • Number of events 11 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.62% 8/1294 • Number of events 8 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.46% 6/1291 • Number of events 7 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Cardiac failure chronic	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.31% 4/1294 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Cardiac failure congestive	2.8% 37/1300 • Number of events 46 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	3.9% 51/1292 • Number of events 57 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	4.7% 61/1294 • Number of events 70 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	3.2% 41/1291 • Number of events 48 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Cardiac perforation	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Cardiac tamponade	0.15% 2/1300 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Cardiac valve disease	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.15% 2/1292 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.15% 2/1294 • Number of events 3 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.15% 2/1291 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Cardiogenic shock	0.31% 4/1300 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.23% 3/1292 • Number of events 3 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.23% 3/1294 • Number of events 3 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.46% 6/1291 • Number of events 6 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Cardiomyopathy	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.23% 3/1292 • Number of events 3 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.31% 4/1291 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Cardiorenal syndrome	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Cardio-respiratory arrest	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Cardiovascular deconditioning	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Cardiovascular disorder	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Conduction disorder	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Cor pulmonale	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Coronary artery disease	12.5% 163/1300 • Number of events 186 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	13.8% 178/1292 • Number of events 198 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	14.6% 189/1294 • Number of events 213 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	11.2% 145/1291 • Number of events 159 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Coronary artery dissection	0.15% 2/1300 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.15% 2/1292 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Coronary artery thrombosis	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Coronary ostial stenosis	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Degenerative mitral valve disease	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Diastolic dysfunction	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Ischaemic cardiomyopathy	0.23% 3/1300 • Number of events 3 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.31% 4/1292 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.39% 5/1294 • Number of events 5 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.31% 4/1291 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Left ventricular dysfunction	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Left ventricular failure	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.15% 2/1294 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Microvascular coronary artery disease	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1291 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Mitral valve disease	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Mitral valve incompetence	0.54% 7/1300 • Number of events 7 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.70% 9/1292 • Number of events 9 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.85% 11/1294 • Number of events 14 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.54% 7/1291 • Number of events 7 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Mitral valve prolapse	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Mitral valve stenosis	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.31% 4/1294 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.15% 2/1291 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Blood and lymphatic system disorders Abdominal lymphadenopathy	0.08% 1/1300 • Number of events 3 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Blood and lymphatic system disorders Anaemia	1.1% 14/1300 • Number of events 15 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.77% 10/1292 • Number of events 11 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	1.1% 14/1294 • Number of events 15 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	1.2% 15/1291 • Number of events 18 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Blood and lymphatic system disorders Anaemia macrocytic	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Blood and lymphatic system disorders Anaemia of chronic disease	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1291 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Blood and lymphatic system disorders Coagulopathy	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1291 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Blood and lymphatic system disorders Haemorrhagic anaemia	0.31% 4/1300 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.15% 2/1292 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.31% 4/1294 • Number of events 5 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.15% 2/1291 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).

Other adverse events
Measure	IV isotonic saline & oral placebo n=1300 participants at risk IV isotonic saline and oral placebo drug capsule IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	IV isotonic saline & oral N-acetylcysteine n=1292 participants at risk IV isotonic saline and oral N-acetylcysteine drug capsule IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	IV isotonic bicarbonate & oral placebo n=1294 participants at risk IV isotonic bicarbonate and oral placebo drug capsule IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	IV isotonic bicarbonate & oral N-acetylcysteine n=1291 participants at risk IV isotonic bicarbonate and oral N-acetylcysteine drug capsule IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.
Cardiac disorders Atrial Fibrillation	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Cardiac Failure Congestive	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Vomiting	0.31% 4/1300 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.85% 11/1292 • Number of events 12 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.70% 9/1294 • Number of events 9 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.77% 10/1291 • Number of events 10 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Palpitations	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Cardiac disorders Tachycardia	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Ear and labyrinth disorders Ear Discomfort	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Eye disorders Visual Impairment	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1291 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Abdominal Discomfort	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.23% 3/1292 • Number of events 3 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1291 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Abdominal Distension	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1291 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Abdominal Pain	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1291 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Abdominal Pain Upper	0.15% 2/1300 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.15% 2/1292 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.15% 2/1294 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.31% 4/1291 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Constipation	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.23% 3/1292 • Number of events 3 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.23% 3/1291 • Number of events 3 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Diarrhoea	0.62% 8/1300 • Number of events 8 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.54% 7/1292 • Number of events 7 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	1.1% 14/1294 • Number of events 14 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.93% 12/1291 • Number of events 12 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Dyspepsia	0.46% 6/1300 • Number of events 6 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	3.1% 40/1292 • Number of events 40 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.31% 4/1294 • Number of events 4 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	3.6% 47/1291 • Number of events 48 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Flatulence	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.15% 2/1291 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Frequent Bowel Movements	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Functional Gastrointestinal Disorder	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Gastrointestinal Disorder	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.23% 3/1292 • Number of events 3 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.23% 3/1291 • Number of events 3 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Hyperchlorhydria	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1291 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Nausea	0.69% 9/1300 • Number of events 9 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	2.4% 31/1292 • Number of events 31 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	1.2% 15/1294 • Number of events 15 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	2.2% 28/1291 • Number of events 28 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Oesophageal Irritation	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1291 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Oesophageal pain	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1291 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Gastrointestinal disorders Oesophagitis	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1291 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
General disorders Asthenia	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
General disorders Catheter site phlebitis	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
General disorders Chest discomfort	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
General disorders Chest Pain	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.15% 2/1291 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
General disorders Chills	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
General disorders Face oedema	0.08% 1/1300 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
General disorders Infusion site extravasation	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.15% 2/1291 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
General disorders Infusion site pruritus	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
General disorders Infusion site reaction	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1291 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
General disorders Non-cardiac chest pain	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1291 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
General disorders Oedema	0.15% 2/1300 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
General disorders Oedema peripheral	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.15% 2/1291 • Number of events 2 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
General disorders Sensation of foreign body	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1291 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Immune system disorders Contrast media allergy	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1292 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1294 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Infections and infestations Cellulitis	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).
Infections and infestations Gastroenteritis	0.00% 0/1300 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1292 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.08% 1/1294 • Number of events 1 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).	0.00% 0/1291 • Serious adverse events are collected from time of consent until 90 days post-angiography (per protocol). Adverse events were collected from time of consent until 35 days post-angiography (per protocol). All adverse events were collected regularly via developed case report forms and submitted electronically to the study electronic data capture (EDC) system. The definition for non-serious adverse events are derived from Veterans Health Administration (VHA) Handbook 1058.01, paragraph (a); The definition for serious adverse events are derived from VHA Handbook 1058.01, paragraph 4(r) and 21 Code of Federal Regulations (CFR) 312.32(a).