Trial Outcomes & Findings for Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF) (NCT NCT00267098)

Last Updated: 2014-03-26

Results Overview

Events include all-cause mortality, heart failure(HF)-related urgent care (a healthcare utilization visit involving intravenous(IV) therapy for heart failure) or significant increase(at least 15%) in LVESVI (a measure of the volume of a patient's left ventricle) from randomization to a later time point. Time from randomization until the subject experienced one of these events served as the outcome measure. LVESVI endpoints occurred primarily at those visits in which LVESVI measurements were required (6, 12, 18, 24 months). Because endpoints such as death or HF urgent care could occur at any time during follow-up, the subject's outcome measure could range from less than 1 month to 105 months (maximum follow-up duration). Primary endpoints and follow-up data occurring after a subject missed a required LVESVI measurement were excluded from the analysis and the table below. The counts reflect the number of subjects meeting each endpoint, and are not necessarily mutually exclusive.

Recruitment status

COMPLETED

Study phase

Target enrollment

918 participants

Primary outcome timeframe

Participants were followed for the duration of the study, an average of 39.8 months post-randomization.

Results posted on

2014-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	No Implant Attempt Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized	Unsuccessful Implants Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted	CRT-P: Biventricular Pacing Arm Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing	CRT-P: Right Ventricular Pacing Arm Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing	CRT-P: Not Randomized Subjects successfully implanted with a CRT-P device who were not randomized	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.	CRT-D: Not Randomized Subjects successfully implanted with a CRT-D device who were not randomized
Overall Study STARTED	109	51	243	241	47	106	101	20
Overall Study COMPLETED	0	0	149	135	10	66	55	5
Overall Study NOT COMPLETED	109	51	94	106	37	40	46	15

Reasons for withdrawal

Reasons for withdrawal
Measure	No Implant Attempt Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized	Unsuccessful Implants Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted	CRT-P: Biventricular Pacing Arm Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing	CRT-P: Right Ventricular Pacing Arm Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing	CRT-P: Not Randomized Subjects successfully implanted with a CRT-P device who were not randomized	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.	CRT-D: Not Randomized Subjects successfully implanted with a CRT-D device who were not randomized
Overall Study Death	0	0	57	66	14	23	28	9
Overall Study Lost to Follow-up	0	0	6	5	2	3	1	1
Overall Study Withdrawal by Subject	8	0	24	21	12	9	12	5
Overall Study Physician Decision	5	0	7	11	5	4	3	0
Overall Study Inclusion/Exclusion Criteria Not Met	96	0	0	0	2	0	0	0
Overall Study Unsuccessful Implant Exit Per Protocol	0	51	0	0	0	0	0	0
Overall Study Site closure	0	0	0	1	0	1	1	0
Overall Study Explanted Medtronic device	0	0	0	1	0	0	0	0
Overall Study Non-Medtronic LV Lead Implanted	0	0	0	0	2	0	0	0
Overall Study Subject listed for heart transplant	0	0	0	0	0	0	1	0
Overall Study Sponsor withdrew subject	0	0	0	1	0	0	0	0

Baseline Characteristics

Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Implant Attempt n=109 Participants Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized	Unsuccessful Implants n=51 Participants Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted	CRT-P: Biventricular Pacing Arm n=243 Participants Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing	CRT-P: Right Ventricular Pacing Arm n=241 Participants Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing	CRT-P: Not Randomized n=47 Participants Subjects successfully implanted with a CRT-P device who were not randomized	CRT-D: Biventricular Pacing Arm n=106 Participants Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm n=101 Participants Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.	CRT-D: Not Randomized n=20 Participants Subjects successfully implanted with a CRT-D device who were not randomized	Total n=918 Participants Total of all reporting groups
Age, Continuous	70.2 years STANDARD_DEVIATION 12.6 • n=5 Participants	71.1 years STANDARD_DEVIATION 11.2 • n=7 Participants	74.4 years STANDARD_DEVIATION 10.2 • n=5 Participants	73.8 years STANDARD_DEVIATION 10.8 • n=4 Participants	79.3 years STANDARD_DEVIATION 7.6 • n=21 Participants	72.0 years STANDARD_DEVIATION 9.3 • n=8 Participants	71.0 years STANDARD_DEVIATION 10.0 • n=8 Participants	74.0 years STANDARD_DEVIATION 9.1 • n=24 Participants	73.2 years STANDARD_DEVIATION 10.6 • n=42 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	14 Participants n=7 Participants	62 Participants n=5 Participants	73 Participants n=4 Participants	18 Participants n=21 Participants	19 Participants n=8 Participants	20 Participants n=8 Participants	4 Participants n=24 Participants	239 Participants n=42 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	37 Participants n=7 Participants	181 Participants n=5 Participants	168 Participants n=4 Participants	29 Participants n=21 Participants	87 Participants n=8 Participants	81 Participants n=8 Participants	16 Participants n=24 Participants	679 Participants n=42 Participants
Race/Ethnicity, Customized Subject did not offer ethnicity	6 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants	5 participants n=4 Participants	1 participants n=21 Participants	4 participants n=8 Participants	3 participants n=8 Participants	0 participants n=24 Participants	27 participants n=42 Participants
Race/Ethnicity, Customized African American	10 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants	10 participants n=4 Participants	0 participants n=21 Participants	4 participants n=8 Participants	4 participants n=8 Participants	1 participants n=24 Participants	40 participants n=42 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	1 participants n=42 Participants
Race/Ethnicity, Customized Caucasian	91 participants n=5 Participants	45 participants n=7 Participants	225 participants n=5 Participants	224 participants n=4 Participants	43 participants n=21 Participants	96 participants n=8 Participants	90 participants n=8 Participants	18 participants n=24 Participants	832 participants n=42 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants	2 participants n=8 Participants	2 participants n=8 Participants	1 participants n=24 Participants	12 participants n=42 Participants
Race/Ethnicity, Customized Native American	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	1 participants n=42 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	2 participants n=8 Participants	0 participants n=24 Participants	5 participants n=42 Participants
Region of Enrollment United States	109 participants n=5 Participants	46 participants n=7 Participants	232 participants n=5 Participants	231 participants n=4 Participants	47 participants n=21 Participants	104 participants n=8 Participants	98 participants n=8 Participants	19 participants n=24 Participants	886 participants n=42 Participants
Region of Enrollment Canada	0 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants	10 participants n=4 Participants	0 participants n=21 Participants	2 participants n=8 Participants	3 participants n=8 Participants	1 participants n=24 Participants	32 participants n=42 Participants

PRIMARY outcome

Timeframe: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.

Population: Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the "No Implant Attempt", "Unsuccessful Implants", "CRT-P: Not Randomized", and "CRT-D: Not Randomized" subgroups were excluded.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=349 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=342 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI) Subjects Experiencing a Primary Endpoint	160 participants	191 participants	—	—
Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI) Subjects with an LVESVI Primary Endpoint	93 participants	136 participants	—	—
Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI) Subjects with an HF Urgent Care Primary Endpoint	70 participants	94 participants	—	—
Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI) Subjects who died	55 participants	66 participants	—	—

SECONDARY outcome

Timeframe: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.

The endpoint is the time to death from any cause. The rate of mortality, as measure by the hazard rate, in each randomization arm will be compared. This outcome includes all post-randomization deaths, whereas the reporting of the primary outcome excluded primary endpoints (including deaths) that occurred after the subject had missed a study-required echocardiogram (used to determine if the LVESVI primary endpoint was met).

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=349 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=342 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
All-Cause Mortality Subjects who died	80 participants	94 participants	—	—
All-Cause Mortality Subjects who did not die	269 participants	248 participants	—	—

SECONDARY outcome

Timeframe: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.

The endpoint will be a subject's time from randomization to either their first heart failure-related hospitalization, or death.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=349 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=342 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
All-Cause Mortality or Heart Failure-related Hospitalization Subjects who died or underwent HF hospitalization	121 participants	135 participants	—	—
All-Cause Mortality or Heart Failure-related Hospitalization Subjects who died	80 participants	94 participants	—	—
All-Cause Mortality or Heart Failure-related Hospitalization Subjects who underwent HF hospitalization	79 participants	92 participants	—	—

SECONDARY outcome

Timeframe: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.

The endpoint will be the time from randomization to either death or a visit (6, 12, 18, 24 month or interim visit) in which the subject undergoes an echocardiogram and the measured left ventricular end systolic volume index (a measure of the size of the subject's left ventricle normalized over their body surface area) is at least 15% greater than the corresponding measured value at randomization. Only LVESVI endpoints/deaths and follow-up data occurring before a subject missed an LVESVI measurement (due to missed visit, echo not performed, etc.) were used in the analysis and included in the table below. The counts reflect the number of subjects meeting each endpoint, and are not mutually exclusive.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=349 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=342 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index Subjects who died or experienced LVESVI event	131 participants	171 participants	—	—
All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index Subjects who died	55 participants	66 participants	—	—
All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index Subjects who experienced LVESVI event	93 participants	136 participants	—	—

SECONDARY outcome

Timeframe: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.

The endpoint is the time from randomization to a subject's first heart failure (HF)-related hospitalization. For each randomization arm, the number of subjects who met the endpoint, experiencing at least one heart failure-related hospitalization post-randomization, are reported, as well as the number of randomized subjects who did not experience any HF hospitalizations post-randomization.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=349 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=342 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
First Heart Failure Hospitalization Subjects experiencing a HF hospitalization	79 participants	92 participants	—	—
First Heart Failure Hospitalization Subjects not experiencing a HF hospitalization	270 participants	250 participants	—	—

SECONDARY outcome

Timeframe: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.

For each subject the endpoint was the days hospitalized for heart failure per patient year, calculated as the total number of days the subject was hospitalized for heart failure divided by the subject's total follow-up time. Only post-randomization data were used.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=349 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=342 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Days Hospitalized for Heart Failure	1.89 Days hospitalized per patient year Standard Deviation 9.52	2.63 Days hospitalized per patient year Standard Deviation 16.08	—	—

SECONDARY outcome

Timeframe: Randomization to 24 Months

Population: For each time point(e.g. 6 months), only subjects with NYHA assessed at both randomization and that time point were included in the analysis. Those who could not be analyzed at a time point(for reasons such as death, exit,missed visit,or NYHA not assessed at visit) are listed under the "Comparative data not available" category for that time point.

The endpoint is a subject's change in New York Heart Association Classification (a measure of the degree of heart failure a subject has on a 4 class scale, with NYHA I being the healthiest score and NYHA IV being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months post-randomization. The change categories listed will be relative to randomization.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=349 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=342 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in New York Heart Association Classification 6 Months: Improved by 2 classes from randomization	5 participants	3 participants	—	—
Change in New York Heart Association Classification 6 Months: Improved by 1 class from randomization	54 participants	43 participants	—	—
Change in New York Heart Association Classification 6 Months: No change from randomization	200 participants	205 participants	—	—
Change in New York Heart Association Classification 6 Months: Worsened by 1 class from randomization	52 participants	41 participants	—	—
Change in New York Heart Association Classification 6 Months: Worsened by 2 classes from randomization	1 participants	1 participants	—	—
Change in New York Heart Association Classification 6 Months: Comparative data not available	37 participants	49 participants	—	—
Change in New York Heart Association Classification 12 Months:Improved by 2 classes from randomization	4 participants	5 participants	—	—
Change in New York Heart Association Classification 12 Months:Improved by 1 class from randomization	54 participants	34 participants	—	—
Change in New York Heart Association Classification 12 Months: No change from randomization	172 participants	172 participants	—	—
Change in New York Heart Association Classification 12 Months: Worsened by 1 class from randomization	49 participants	64 participants	—	—
Change in New York Heart Association Classification 12 Months:Worsened by 2 classes from randomization	2 participants	3 participants	—	—
Change in New York Heart Association Classification 12 Months: Comparative data not available	68 participants	64 participants	—	—
Change in New York Heart Association Classification 18 Months:Improved by 2 classes from randomization	3 participants	2 participants	—	—
Change in New York Heart Association Classification 18 Months: Improved by 1 class from randomization	43 participants	45 participants	—	—
Change in New York Heart Association Classification 18 Months: No change from randomization	142 participants	141 participants	—	—
Change in New York Heart Association Classification 18 Months: Worsened by 1 class from randomization	50 participants	56 participants	—	—
Change in New York Heart Association Classification 18 Months:Worsened by 2 classes from randomization	4 participants	6 participants	—	—
Change in New York Heart Association Classification 18 Months: Comparative data not available	107 participants	92 participants	—	—
Change in New York Heart Association Classification 24 Months:Improved by 2 classes from randomization	2 participants	3 participants	—	—
Change in New York Heart Association Classification 24 Months: Improved by 1 class from randomization	35 participants	36 participants	—	—
Change in New York Heart Association Classification 24 Months: No change from randomization	135 participants	126 participants	—	—
Change in New York Heart Association Classification 24 Months:Worsened by 1 class from randomization	41 participants	54 participants	—	—
Change in New York Heart Association Classification 24 Months:Worsened by 2 classes from randomization	4 participants	3 participants	—	—
Change in New York Heart Association Classification 24 Months: Comparative data not available	132 participants	120 participants	—	—

SECONDARY outcome

Timeframe: Randomization to 24 Months

Population: For each time point(e.g. 6 months), only subjects with HF Stage assessed at randomization and that time point were included in the analysis. Those who could not be analyzed at a time point(for reasons such as death, exit,missed visit,or HF Stage not assessed) are listed under the "Comparative data not available" category for that time point.

The endpoint is a subject's change in Heart Failure Stage (a measure of the degree of heart failure a subject has on a 4 stage scale (A, B, C, D), with Class A being the healthiest score and Class D being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=349 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=342 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Heart Failure Stage 6 Months: Improved by 2 stages since randomization	1 participants	0 participants	—	—
Change in Heart Failure Stage 6 Months: Improved by 1 stage since randomization	11 participants	5 participants	—	—
Change in Heart Failure Stage 6 Months: No change from randomization	296 participants	274 participants	—	—
Change in Heart Failure Stage 6 Months: Worsened by 1 stage since randomization	2 participants	14 participants	—	—
Change in Heart Failure Stage 6 Months: Worsened by 2 stages since randomization	1 participants	0 participants	—	—
Change in Heart Failure Stage 6 Months: Comparative data not available	38 participants	49 participants	—	—
Change in Heart Failure Stage 12 Months:Improved by 2 stages since randomization	0 participants	0 participants	—	—
Change in Heart Failure Stage 12 Months:Improved by 1 stage since randomization	7 participants	8 participants	—	—
Change in Heart Failure Stage 12 Months: No change since randomization	258 participants	244 participants	—	—
Change in Heart Failure Stage 12 Months: Worsened by 1 stage since randomization	15 participants	23 participants	—	—
Change in Heart Failure Stage 12 Months:Worsened by 2 stages since randomization	1 participants	1 participants	—	—
Change in Heart Failure Stage 12 Months: Comparative data not available	68 participants	66 participants	—	—
Change in Heart Failure Stage 18 Months:Improved by 2 stages since randomization	0 participants	0 participants	—	—
Change in Heart Failure Stage 18 Months:Improved by 1 stage since randomization	4 participants	5 participants	—	—
Change in Heart Failure Stage 18 Months: No change since randomization	222 participants	225 participants	—	—
Change in Heart Failure Stage 18 Months:Worsened by 1 stage since randomization	16 participants	18 participants	—	—
Change in Heart Failure Stage 18 Months:Worsened by 2 stages since randomization	0 participants	1 participants	—	—
Change in Heart Failure Stage 18 Months: Comparative data not available	107 participants	93 participants	—	—
Change in Heart Failure Stage 24 Months:Improved by 2 stages since randomization	0 participants	0 participants	—	—
Change in Heart Failure Stage 24 Months: Improved by 1 stage since randomization	4 participants	6 participants	—	—
Change in Heart Failure Stage 24 Months: No change since randomization	196 participants	197 participants	—	—
Change in Heart Failure Stage 24 Months:Worsened by 1 stage since randomization	16 participants	19 participants	—	—
Change in Heart Failure Stage 24 Months:Worsened by 2 stages since randomization	1 participants	0 participants	—	—
Change in Heart Failure Stage 24 Months: Comparative data not available	132 participants	120 participants	—	—

SECONDARY outcome

Timeframe: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.

Population: Because indications for defibrillation devices like CRT-Ds are defined by characteristics that relate to medication guidelines, medication results are presented separately for each device group. Medications were assessed only for subjects who completed visits (denoted as "Subjects with Medications Assessed").

The endpoints are what classes of drugs (e.g. Beta blockers, Diuretics, Nitrates, etc.) each subject was on at the time of scheduled visits (e.g Randomization, 6 months, 12 months, etc.)

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=243 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=241 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm n=106 Participants Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm n=101 Participants Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Cardiovascular Medications Randomization: Subjects on Beta Blockers	186 participants	191 participants	98 participants	93 participants
Change in Cardiovascular Medications Randomization: Subjects on Vasodilators/Nitrates	53 participants	44 participants	31 participants	20 participants
Change in Cardiovascular Medications Randomization: Subjects on ACE-Inhibitors/ARBs	173 participants	179 participants	93 participants	84 participants
Change in Cardiovascular Medications Randomization: Subjects on Aldosterone Antagonists	33 participants	25 participants	19 participants	25 participants
Change in Cardiovascular Medications Randomization: Subjects on Diuretics	156 participants	158 participants	74 participants	74 participants
Change in Cardiovascular Medications 6 Months: Subjects with Medications Assessed	226 participants	207 participants	94 participants	89 participants
Change in Cardiovascular Medications 6 Months: Subjects on ACE-Inhibitors/ARBs	162 participants	152 participants	77 participants	73 participants
Change in Cardiovascular Medications 6 Months: Subjects on Beta Blockers	175 participants	171 participants	87 participants	79 participants
Change in Cardiovascular Medications 6 Months: Subjects on Vasodilators/Nitrates	46 participants	42 participants	24 participants	12 participants
Change in Cardiovascular Medications 6 Months: Subjects on Aldosterone Antagonists	31 participants	21 participants	20 participants	25 participants
Change in Cardiovascular Medications 6 Months: Subjects on Diuretics	148 participants	137 participants	66 participants	70 participants
Change in Cardiovascular Medications 12 Months: Subjects with Medications Assessed	205 participants	200 participants	83 participants	81 participants
Change in Cardiovascular Medications 12 Months: Subjects on ACE-Inhibitors/ARBs	147 participants	151 participants	72 participants	70 participants
Change in Cardiovascular Medications 12 Months: Subjects on Beta Blockers	158 participants	170 participants	79 participants	75 participants
Change in Cardiovascular Medications 12 Months: Subjects on Vasodilators/Nitrates	45 participants	43 participants	22 participants	13 participants
Change in Cardiovascular Medications 12 Months: Subjects on Aldosterone Antagonists	23 participants	20 participants	13 participants	21 participants
Change in Cardiovascular Medications 12 Months: Subjects on Diuretics	133 participants	131 participants	57 participants	60 participants
Change in Cardiovascular Medications 18 Months: Subjects with Medications Assessed	169 participants	181 participants	78 participants	72 participants
Change in Cardiovascular Medications 18 Months: Subjects on ACE-Inhibitors/ARBs	121 participants	137 participants	62 participants	58 participants
Change in Cardiovascular Medications 18 Months: Subjects on Beta Blockers	134 participants	152 participants	75 participants	63 participants
Change in Cardiovascular Medications 18 Months: Subjects on Vasodilators/Nitrates	36 participants	44 participants	22 participants	11 participants
Change in Cardiovascular Medications 18 Months: Subjects on Aldosterone Antagonists	16 participants	21 participants	9 participants	20 participants
Change in Cardiovascular Medications 18 Months: Subjects on Diuretics	111 participants	125 participants	51 participants	59 participants
Change in Cardiovascular Medications 24 Months: Subjects with Medications Assessed	152 participants	157 participants	69 participants	67 participants
Change in Cardiovascular Medications 24 Months: Subjects on ACE-Inhibitors/ARBs	114 participants	119 participants	58 participants	56 participants
Change in Cardiovascular Medications 24 Months: Subjects on Beta Blockers	118 participants	133 participants	65 participants	63 participants
Change in Cardiovascular Medications 24 Months: Subjects on Vasodilators/Nitrates	28 participants	37 participants	23 participants	10 participants
Change in Cardiovascular Medications 24 Months: Subjects on Aldosterone Antagonists	18 participants	15 participants	13 participants	18 participants
Change in Cardiovascular Medications 24 Months: Subjects on Diuretics	97 participants	104 participants	47 participants	56 participants
Change in Cardiovascular Medications 30 Months: Subjects with Medications Assessed	130 participants	131 participants	53 participants	57 participants
Change in Cardiovascular Medications 30 Months: Subjects on ACE-Inhibitors/ARBs	92 participants	102 participants	42 participants	47 participants
Change in Cardiovascular Medications 30 Months: Subjects on Beta Blockers	104 participants	114 participants	51 participants	56 participants
Change in Cardiovascular Medications 30 Months: Subjects on Vasodilators/Nitrates	23 participants	28 participants	16 participants	11 participants
Change in Cardiovascular Medications 30 Months: Subjects on Aldosterone Antagonists	14 participants	14 participants	10 participants	15 participants
Change in Cardiovascular Medications 30 Months: Subjects on Diuretics	82 participants	90 participants	36 participants	50 participants
Change in Cardiovascular Medications 36 Months: Subjects with Medications Assessed	109 participants	112 participants	42 participants	44 participants
Change in Cardiovascular Medications 36 Months: Subjects on ACE-Inhibitors/ARBs	76 participants	85 participants	30 participants	37 participants
Change in Cardiovascular Medications 36 Months: Subjects on Beta Blockers	86 participants	97 participants	41 participants	44 participants
Change in Cardiovascular Medications 36 Months: Subjects on Vasodilators/Nitrates	21 participants	24 participants	14 participants	9 participants
Change in Cardiovascular Medications 36 Months: Subjects on Aldosterone Antagonists	10 participants	19 participants	8 participants	10 participants
Change in Cardiovascular Medications 36 Months: Subjects on Diuretics	69 participants	79 participants	34 participants	37 participants
Change in Cardiovascular Medications 42 Months: Subjects with Medications Assessed	94 participants	99 participants	38 participants	42 participants
Change in Cardiovascular Medications 42 Months: Subjects on ACE-Inhibitors/ARBs	69 participants	73 participants	27 participants	35 participants
Change in Cardiovascular Medications 42 Months: Subjects on Beta Blockers	75 participants	86 participants	35 participants	42 participants
Change in Cardiovascular Medications 42 Months: Subjects on Vasodilators/Nitrates	15 participants	22 participants	12 participants	10 participants
Change in Cardiovascular Medications 42 Months: Subjects on Aldosterone Antagonists	8 participants	13 participants	9 participants	12 participants
Change in Cardiovascular Medications 42 Months: Subjects on Diuretics	57 participants	71 participants	31 participants	39 participants

SECONDARY outcome

Timeframe: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.

Adverse events that subjects experienced after they were randomized were compared between arms with regard to several categories such as heart failure (HF)-relatedness, relatedness to the implant procedure, and relatedness to the implanted system, including individual components such as the left ventricular (LV) lead and the CRT-P or CRT-D generator.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=243 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=241 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm n=106 Participants Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm n=101 Participants Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Frequency of Adverse Events Post-randomization Subjects with procedure-related AE(s)	37 participants	7 participants	7 participants	2 participants
Frequency of Adverse Events Post-randomization Subjects with system-related AE(s)	56 participants	31 participants	47 participants	24 participants
Frequency of Adverse Events Post-randomization Subjects with LV lead-related AE(s)	40 participants	12 participants	14 participants	4 participants
Frequency of Adverse Events Post-randomization Subjects with CRT-P/CRT-D related AE(s)	12 participants	17 participants	36 participants	18 participants
Frequency of Adverse Events Post-randomization Subjects with HF-related AE(s)	73 participants	106 participants	45 participants	47 participants

SECONDARY outcome

Timeframe: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.

Cardiovascular-related healthcare utilizations (HCUs), such as hospitalizations, Emergency Department visits, urgent care visits, and clinic visits that subjects experienced after being randomized were summarized for each randomization arm

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=349 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=342 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Cardiovascular-related Healthcare Utilizations Subjects with a post-randomization CV HCU	264 participants	263 participants	—	—
Cardiovascular-related Healthcare Utilizations Subjects with post-randomization hospitalization	164 participants	162 participants	—	—
Cardiovascular-related Healthcare Utilizations Subjects with post-randomization ED visit	118 participants	128 participants	—	—
Cardiovascular-related Healthcare Utilizations Subjects with post-randomization urgent care visit	12 participants	12 participants	—	—
Cardiovascular-related Healthcare Utilizations Subjects with post-randomization clinic visit	214 participants	220 participants	—	—

SECONDARY outcome

Timeframe: Randomization to 6 Months

The endpoint will be a subject's change in Quality of Life score from randomization to 6 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 6 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life. Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=304 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=289 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Quality of Life at 6 Months	5 units on a scale Standard Deviation 20.3	0.3 units on a scale Standard Deviation 19.4	—	—

SECONDARY outcome

Timeframe: Randomization to 12 months

The endpoint will be a subject's change in Quality of Life score from randomization to 12 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 12 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life. Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=274 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=273 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Quality of Life at 12 Months	3.9 units on a scale Standard Deviation 20.1	0.9 units on a scale Standard Deviation 18.9	—	—

SECONDARY outcome

Timeframe: Randomization to 18 Months

The endpoint will be a subject's change in Quality of Life score from randomization to 18 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 18 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life. Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=237 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=244 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Quality of Life at 18 Months	2.3 units on a scale Standard Deviation 20.5	0.5 units on a scale Standard Deviation 18.1	—	—

SECONDARY outcome

Timeframe: Randomization to 24 Months

The endpoint will be a subject's change in Quality of Life score from randomization to 24 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 24 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life. Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=214 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=218 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Quality of Life at 24 Months	2.6 units on a scale Standard Deviation 20.5	1.5 units on a scale Standard Deviation 18.8	—	—

SECONDARY outcome

Timeframe: Randomization to 6 Months

The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 6 month - randomization visit difference in LVEF value.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=282 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=273 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 6 Months	3.0 percentage Standard Deviation 8.4	-0.3 percentage Standard Deviation 8.9	—	—

SECONDARY outcome

Timeframe: Randomization to 12 Months

The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 12 month - randomization visit difference in LVEF value.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=263 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=260 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 12 Months	2.7 percentage Standard Deviation 9.3	-0.5 percentage Standard Deviation 9.4	—	—

SECONDARY outcome

Timeframe: Randomization to 18 Months

The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 18 month - randomization visit difference in LVEF value.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=223 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=226 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 18 Months	2.7 percentage Standard Deviation 9.5	0.4 percentage Standard Deviation 10.1	—	—

SECONDARY outcome

Timeframe: Randomization to 24 Months

The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 24 month - randomization visit difference in LVEF value.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=192 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=205 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 24 Months	2.0 percentage Standard Deviation 9.6	-1.6 percentage Standard Deviation 10.5	—	—

SECONDARY outcome

Timeframe: Randomization to 6 Months

The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=279 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=272 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 6 Months	-6.8 ml/square meter of body surface area Standard Deviation 17.1	0.4 ml/square meter of body surface area Standard Deviation 17.7	—	—

SECONDARY outcome

Timeframe: Randomization to 12 Months

The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=260 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=256 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 12 Months	-6.8 ml/square meter of body surface area Standard Deviation 18.7	0.5 ml/square meter of body surface area Standard Deviation 20.2	—	—

SECONDARY outcome

Timeframe: Randomization to 18 Months

The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=219 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=225 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 18 Months	-8.8 ml/square meter of body surface area Standard Deviation 18.9	-0.5 ml/square meter of body surface area Standard Deviation 19.9	—	—

SECONDARY outcome

Timeframe: Randomization to 24 Months

The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=187 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=204 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 24 Months	-6.0 ml/square meter of body surface area Standard Deviation 22.6	1.4 ml/square meter of body surface area Standard Deviation 21.3	—	—

SECONDARY outcome

Timeframe: Randomization to 6 Months

The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=281 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=273 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 6 Months	-6.2 ml/square meter of body surface area Standard Deviation 19.2	-0.3 ml/square meter of body surface area Standard Deviation 19.5	—	—

SECONDARY outcome

Timeframe: Randomization to 12 Months

The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=261 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=256 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 12 Months	-7.0 ml/square meter of body surface area Standard Deviation 20.6	-1.1 ml/square meter of body surface area Standard Deviation 22.2	—	—

SECONDARY outcome

Timeframe: Randomization to 18 Months

The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=220 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=225 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 18 Months	-9.8 ml/square meter of body surface area Standard Deviation 21.4	-0.8 ml/square meter of body surface area Standard Deviation 22.4	—	—

SECONDARY outcome

Timeframe: Randomization to 24 Months

The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=189 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=206 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 24 Months	-6.9 ml/square meter of body surface area Standard Deviation 24.9	-0.1 ml/square meter of body surface area Standard Deviation 23.7	—	—

SECONDARY outcome

Timeframe: Randomization to 6 Months

The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 6 months. For each subject the measurement was calculated as 6 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=220 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=208 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular Mass (LV Mass) From Randomization to 6 Months	-8.4 grams Standard Deviation 43.1	-4.2 grams Standard Deviation 47.5	—	—

SECONDARY outcome

Timeframe: Randomization to 12 Months

The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 12 months. For each subject the measurement was calculated as 12 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=211 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=199 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular Mass (LV Mass) From Randomization to 12 Months	-15.8 grams Standard Deviation 46.8	-4.7 grams Standard Deviation 52.4	—	—

SECONDARY outcome

Timeframe: Randomization to 18 Months

The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 18 months. For each subject the measurement was calculated as 18 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=168 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=176 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular Mass (LV Mass) From Randomization to 18 Months	-16.8 grams Standard Deviation 48.8	-7.2 grams Standard Deviation 49.8	—	—

SECONDARY outcome

Timeframe: Randomization to 24 Months

The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 24 months. For each subject the measurement was calculated as 24 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=150 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=163 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular Mass (LV Mass) From Randomization to 24 Months	-19.4 grams Standard Deviation 45.1	-6.8 grams Standard Deviation 49.6	—	—

SECONDARY outcome

Timeframe: Randomization to 6 Months

The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 6 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=254 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=242 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 6 Months	-0.1 cm Standard Deviation 0.6	0.0 cm Standard Deviation 0.6	—	—

SECONDARY outcome

Timeframe: Randomization to 12 Months

The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 12 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=241 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=232 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 12 Months	-0.1 cm Standard Deviation 0.7	0.0 cm Standard Deviation 0.7	—	—

SECONDARY outcome

Timeframe: Randomization to 18 Months

The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 18 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=201 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=204 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 18 Months	-0.2 cm Standard Deviation 0.6	0.0 cm Standard Deviation 0.7	—	—

SECONDARY outcome

Timeframe: Randomization to 24 Months

The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 24 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=175 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=186 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 24 Months	-0.3 cm Standard Deviation 0.7	0.0 cm Standard Deviation 0.7	—	—

SECONDARY outcome

Timeframe: Randomization to 6 Months

The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 6 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=250 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=241 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 6 Months	-0.1 cm Standard Deviation 0.6	0.0 cm Standard Deviation 0.7	—	—

SECONDARY outcome

Timeframe: Randomization to 12 Months

The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 12 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=239 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=231 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 12 Months	0.0 cm Standard Deviation 0.7	0.1 cm Standard Deviation 0.7	—	—

SECONDARY outcome

Timeframe: Randomization to 18 Months

The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 18 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=199 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=204 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 18 Months	-0.1 cm Standard Deviation 0.7	0.0 cm Standard Deviation 0.7	—	—

SECONDARY outcome

Timeframe: Randomization to 24 Months

The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 24 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=173 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=185 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 24 Months	-0.1 cm Standard Deviation 0.8	0.1 cm Standard Deviation 0.7	—	—

SECONDARY outcome

Timeframe: Randomization to 6 Months

The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 6 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=247 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=225 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Mitral Regurgitation From Randomization to 6 Months	-1.3 percentage of left atrial area Standard Deviation 12.4	-0.6 percentage of left atrial area Standard Deviation 11.2	—	—

SECONDARY outcome

Timeframe: Randomization to 12 Months

The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 12 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=235 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=214 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Mitral Regurgitation From Randomization to 12 Months	-1.3 percentage of left atrial area Standard Deviation 12.0	-0.8 percentage of left atrial area Standard Deviation 12.6	—	—

SECONDARY outcome

Timeframe: Randomization to 18 Months

The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 18 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=188 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=195 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Mitral Regurgitation From Randomization to 18 Months	-1.9 percentage of left atrial area Standard Deviation 12.1	-1.9 percentage of left atrial area Standard Deviation 11.5	—	—

SECONDARY outcome

Timeframe: Randomization to 24 Months

The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 24 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=173 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=173 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Mitral Regurgitation From Randomization to 24 Months	-1.1 percentage of left atrial area Standard Deviation 13.6	-0.5 percentage of left atrial area Standard Deviation 11.4	—	—

SECONDARY outcome

Timeframe: Randomization to 6 Months

The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit value.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=275 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=268 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Cardiac Index From Randomization to 6 Months	0 liters per minute per squared meter Standard Deviation 0.6	-0.1 liters per minute per squared meter Standard Deviation 0.7	—	—

SECONDARY outcome

Timeframe: Randomization to 12 Months

The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit value.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=257 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=250 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Cardiac Index From Randomization to 12 Months	-0.1 liters per minute per squared meter Standard Deviation 0.6	-0.2 liters per minute per squared meter Standard Deviation 0.6	—	—

SECONDARY outcome

Timeframe: Randomization to 18 Months

The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit value.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=215 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=218 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Cardiac Index From Randomization to 18 Months	-0.1 liters per minute per squared meter Standard Deviation 0.7	0 liters per minute per squared meter Standard Deviation 0.7	—	—

SECONDARY outcome

Timeframe: Randomization to 24 Months

The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit value.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=186 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=198 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Cardiac Index From Randomization to 24 Months	-0.1 liters per minute per squared meter Standard Deviation 0.7	-0.2 liters per minute per squared meter Standard Deviation 0.7	—	—

SECONDARY outcome

Timeframe: Randomization to 6 Months

The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 6 month visit. The measure will be the 6 month - randomization visit difference in IVMD.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=220 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=208 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 6 Months	49.9 ms Standard Deviation 134.2	-4.2 ms Standard Deviation 136.1	—	—

SECONDARY outcome

Timeframe: Randomization to 12 Months

The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 12 month visit. The measure will be the 12 month - randomization visit difference in IVMD.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=202 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=198 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 12 Months	38.5 ms Standard Deviation 121.9	0.4 ms Standard Deviation 128.9	—	—

SECONDARY outcome

Timeframe: Randomization to 18 Months

The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 18 month visit. The measure will be the 18 month - randomization visit difference in IVMD.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=173 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=172 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 18 Months	55.1 ms Standard Deviation 135.7	-0.8 ms Standard Deviation 136.7	—	—

SECONDARY outcome

Timeframe: Randomization to 24 Months

The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 24 month visit. The measure will be the 24 month - randomization visit difference in IVMD.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=150 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=160 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 24 Months	48.6 ms Standard Deviation 138.1	-4.9 ms Standard Deviation 133.3	—	—

SECONDARY outcome

Timeframe: Randomization to 6 Months

The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=221 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=194 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 6 Months	0 ratio Standard Deviation 0.6	0 ratio Standard Deviation 0.7	—	—

SECONDARY outcome

Timeframe: Randomization to 12 Months

The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=208 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=188 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 12 Months	0.1 ratio Standard Deviation 0.7	0.2 ratio Standard Deviation 1.0	—	—

SECONDARY outcome

Timeframe: Randomization to 18 Months

The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=174 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=159 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 18 Months	0.1 ratio Standard Deviation 0.8	0.1 ratio Standard Deviation 0.8	—	—

SECONDARY outcome

Timeframe: Randomization to 24 Months

The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=160 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=141 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 24 Months	0.2 ratio Standard Deviation 0.8	0.1 ratio Standard Deviation 0.9	—	—

SECONDARY outcome

Timeframe: Randomization to 6 Months

The endpoint will be a subject's Clinical Composite Score at 6 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=349 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=342 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Clinical Composite Score at 6 Months Improved	184 participants	133 participants	—	—
Clinical Composite Score at 6 Months Unchanged	83 participants	113 participants	—	—
Clinical Composite Score at 6 Months Worsened	82 participants	96 participants	—	—

SECONDARY outcome

Timeframe: Randomization to 12 Months

The endpoint will be a subject's Clinical Composite Score at 12 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=345 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=341 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Clinical Composite Score at 12 Months Improved	160 participants	117 participants	—	—
Clinical Composite Score at 12 Months Unchanged	82 participants	78 participants	—	—
Clinical Composite Score at 12 Months Worsened	103 participants	146 participants	—	—

SECONDARY outcome

Timeframe: Randomization to 18 Months

The endpoint will be a subject's Clinical Composite Score at 18 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=325 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=323 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Clinical Composite Score at 18 Months Improved	137 participants	103 participants	—	—
Clinical Composite Score at 18 Months Unchanged	68 participants	70 participants	—	—
Clinical Composite Score at 18 Months Worsened	120 participants	150 participants	—	—

SECONDARY outcome

Timeframe: Randomization to 24 Months

The endpoint will be a subject's Clinical Composite Score at 24 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=308 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=314 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Clinical Composite Score at 24 Months Improved	118 participants	94 participants	—	—
Clinical Composite Score at 24 Months Unchanged	70 participants	59 participants	—	—
Clinical Composite Score at 24 Months Worsened	120 participants	161 participants	—	—

SECONDARY outcome

Timeframe: Initial Implant Procedure

Population: For this outcome measure, only subjects in the "No Implant Attempt" subgroup were excluded.

The endpoint will be whether each subject who underwent an implant attempt of a Cardiac Resynchronization Therapy device, be it a pacing only device (CRT-P) or a pacing device with defibrillation capability (CRT-D), had a successful procedure (i.e. the generator, left ventricular lead, and right ventricular lead were successfully implanted). Only one implant attempt was allowed.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=561 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=248 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
CRT-P and CRT-D System Implant Success Subjects successfully implanted	531 participants	227 participants	—	—
CRT-P and CRT-D System Implant Success Subjects not successfully implanted	30 participants	21 participants	—	—

SECONDARY outcome

Timeframe: Participants were followed for the duration of the study, an average of 37.9 months post-randomization among CRT-D subjects.

Population: Only randomized subjects in the CRT-D device group were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data recorded by CRT-D devices. Subjects in the "No Implant Attempt", "Unsuccessful Implants", "CRT-D: Not Randomized", and all CRT-P subgroups were excluded.

Among subjects implanted with a Cardiac Resynchronization Therapy with Defibrillation device (CRT-D) and randomized, the endpoint was the time from randomization until the subject experienced a ventricular tachyarrhythmia. For each randomization arm, the number of CRT-D subjects who experienced at least one ventricular tachyarrhythmia post-randomization is reported, as well as the number of CRT-D subjects who did not experience one or more ventricular tachyarrhythmias post-randomization.

Outcome measures

Outcome measures
Measure	Biventricular Pacing Arm n=106 Participants Subjects randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=101 Participants Subjects randomized to receive right ventricular pacing.	CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing	CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
Incidence of Ventricular Tachyarrhythmias Subjects who experienced VT/VF	39 participants	31 participants	—	—
Incidence of Ventricular Tachyarrhythmias Subjects who did not experience VT/VF	67 participants	70 participants	—	—

Adverse Events

Biventricular Pacing Arm

Serious events: 223 serious events

Other events: 193 other events

Deaths: 0 deaths

Right Ventricular Pacing Arm

Serious events: 219 serious events

Other events: 181 other events

Deaths: 0 deaths

CRT: Not Randomized

Serious events: 41 serious events

Other events: 16 other events

Deaths: 0 deaths

Unsuccessful Implants

Serious events: 6 serious events

Other events: 8 other events

Deaths: 0 deaths

No Implant Attempt

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Biventricular Pacing Arm n=349 participants at risk Subjects who were implanted with a CRT device and randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=342 participants at risk Subjects who were implanted with a CRT device and randomized to receive right ventricular pacing	CRT: Not Randomized n=67 participants at risk Subjects successfully implanted with a CRT device who were not randomized	Unsuccessful Implants n=51 participants at risk Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted	No Implant Attempt n=109 participants at risk Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
Blood and lymphatic system disorders Anaemia	0.86% 3/349 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.88% 3/342 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Blood and lymphatic system disorders Anaemia of chronic disease	0.29% 1/349 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Acute coronary syndrome	2.3% 8/349 • Number of events 11 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	2.3% 8/342 • Number of events 8 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Acute myocardial infarction	2.0% 7/349 • Number of events 7 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.88% 3/342 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	3.0% 2/67 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Angina pectoris	2.6% 9/349 • Number of events 10 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	2.9% 10/342 • Number of events 11 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Angina unstable	1.4% 5/349 • Number of events 7 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.8% 6/342 • Number of events 7 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Aortic valve incompetence	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Atrial fibrillation	4.0% 14/349 • Number of events 19 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	7.6% 26/342 • Number of events 37 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Atrial flutter	1.1% 4/349 • Number of events 6 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.2% 4/342 • Number of events 6 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Atrial tachycardia	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.58% 2/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Cardiac failure	28.7% 100/349 • Number of events 196 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	34.2% 117/342 • Number of events 215 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	29.9% 20/67 • Number of events 28 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	3.9% 2/51 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Cardiac tamponade	1.1% 4/349 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Cardiac valve disease	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Cardio-respiratory arrest	0.57% 2/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.88% 3/342 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Cardiomyopathy	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.88% 3/342 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Coronary artery disease	2.9% 10/349 • Number of events 10 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.8% 6/342 • Number of events 7 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.92% 1/109 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Intracardiac thrombus	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.92% 1/109 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Mitral valve incompetence	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Myocardial infarction	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.8% 6/342 • Number of events 6 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Pericardial effusion	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Stress cardiomyopathy	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Supraventricular tachycardia	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Tachycardia	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Ventricular arrhythmia	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Ventricular fibrillation	1.4% 5/349 • Number of events 6 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	2.0% 7/342 • Number of events 7 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Ventricular tachycardia	3.2% 11/349 • Number of events 17 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	4.1% 14/342 • Number of events 20 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Eye disorders Amaurosis fugax	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Gastrointestinal disorders Gastritis atrophic	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Gastrointestinal disorders Pancreatitis	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Cardiac arrest	1.4% 5/349 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.8% 6/342 • Number of events 6 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Bacterial pyelonephritis	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Bronchitis	1.1% 4/349 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.2% 4/342 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Cellulitis	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.2% 4/342 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Device related infection	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	3.0% 2/67 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Diabetic foot infection	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Endocarditis	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.58% 2/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Escherichia bacteraemia	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Gangrene	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Implant site cellulitis	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Implant site infection	0.57% 2/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.58% 2/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Klebsiella infection	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
General disorders Adverse drug reaction	1.4% 5/349 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	2.0% 7/342 • Number of events 8 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	2.0% 1/51 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
General disorders Asthenia	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
General disorders Chest discomfort	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
General disorders Chest pain	0.86% 3/349 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.88% 3/342 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
General disorders Implant site erosion	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
General disorders Implant site haematoma	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.58% 2/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
General disorders Implant site pain	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
General disorders Multi-organ failure	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
General disorders Non-cardiac chest pain	0.57% 2/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
General disorders Oedema peripheral	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
General disorders Sudden death	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.58% 2/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Immune system disorders Sarcoidosis	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Bacteraemia	0.57% 2/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Cardiac procedure complication	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Complication of device insertion	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Defibrillation threshold increased	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Device failure	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Device lead damage	0.86% 3/349 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.88% 3/342 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Device migration	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Dialysis device complication	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Elevated pacing threshold	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Failure to capture	0.57% 2/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.2% 4/342 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Lower respiratory tract infection	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Lung infection	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Osteomyelitis	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Osteomyelitis chronic	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Pneumonia	8.0% 28/349 • Number of events 57 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	10.8% 37/342 • Number of events 50 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	9.0% 6/67 • Number of events 8 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Pyelonephritis	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Sepsis	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Sepsis syndrome	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Septic shock	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Staphylococcal sepsis	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Urinary tract infection	2.0% 7/349 • Number of events 9 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.8% 6/342 • Number of events 6 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	3.0% 2/67 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Urosepsis	1.1% 4/349 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.58% 2/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Vaginitis bacterial	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Arterial injury	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Arteriovenous fistula site haemorrhage	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Arteriovenous graft thrombosis	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Metabolism and nutrition disorders Diabetic foot	0.29% 1/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Metabolism and nutrition disorders Failure to thrive	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Inappropriate device stimulation of tissue	1.7% 6/349 • Number of events 6 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Lead dislodgement	3.4% 12/349 • Number of events 13 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	3.8% 13/342 • Number of events 15 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	4.5% 3/67 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	5.9% 3/51 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Lower limb fracture	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Oversensing	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Pacemaker complication	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.58% 2/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Procedural hypotension	0.57% 2/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.58% 2/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Subdural haematoma	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.88% 3/342 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Investigations Ejection fraction decreased	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.88% 3/342 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Metabolism and nutrition disorders Dehydration	4.0% 14/349 • Number of events 16 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	3.8% 13/342 • Number of events 14 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Metabolism and nutrition disorders Hyperkalaemia	0.57% 2/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.58% 2/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.29% 1/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.58% 2/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.58% 2/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric cancer	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Nervous system disorders Aphasia	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Nervous system disorders Carotid artery disease	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Nervous system disorders Carotid artery stenosis	0.57% 2/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.2% 4/342 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Nervous system disorders Cerebral artery embolism	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Nervous system disorders Cerebral haemorrhage	0.86% 3/349 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Nervous system disorders Cerebrovascular accident	2.9% 10/349 • Number of events 12 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	4.1% 14/342 • Number of events 16 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Nervous system disorders Convulsion	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Renal and urinary disorders Calculus ureteric	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Nervous system disorders Encephalopathy	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Nervous system disorders Haemorrhage intracranial	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Nervous system disorders Intraventricular haemorrhage	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.88% 3/342 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Nervous system disorders Ischaemic stroke	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Nervous system disorders Presyncope	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Nervous system disorders Syncope	0.86% 3/349 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	2.3% 8/342 • Number of events 9 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Nervous system disorders Transient ischaemic attack	1.1% 4/349 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	2.0% 7/342 • Number of events 7 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Psychiatric disorders Confusional state	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Renal and urinary disorders Bladder obstruction	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Renal and urinary disorders Calculus bladder	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Renal and urinary disorders Calculus urinary	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Renal and urinary disorders Cystitis glandularis	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Renal and urinary disorders Haematuria	1.1% 4/349 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Renal and urinary disorders Nephrolithiasis	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Renal and urinary disorders Obstructive uropathy	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Renal and urinary disorders Renal artery stenosis	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Renal and urinary disorders Renal cyst	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Renal and urinary disorders Renal failure	1.1% 4/349 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.8% 6/342 • Number of events 6 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Renal and urinary disorders Renal failure acute	5.2% 18/349 • Number of events 20 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	4.4% 15/342 • Number of events 17 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	4.5% 3/67 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Renal and urinary disorders Renal failure chronic	1.4% 5/349 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Renal and urinary disorders Renal infarct	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Renal and urinary disorders Urinary retention	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	4.9% 17/349 • Number of events 23 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	3.2% 11/342 • Number of events 17 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 5/342 • Number of events 6 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.57% 2/349 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma stage unspecified	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Haemopneumothorax	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	2.0% 1/51 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.58% 2/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.58% 2/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Mediastinal mass	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.4% 5/349 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.58% 2/342 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.86% 3/349 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.58% 2/342 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 5/349 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.8% 6/342 • Number of events 6 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	3.0% 2/67 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Skin and subcutaneous tissue disorders Drug eruption	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Skin and subcutaneous tissue disorders Skin ulcer	0.57% 2/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.2% 4/342 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Surgical and medical procedures Cardiac pacemaker insertion	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Surgical and medical procedures Medical device change	11.2% 39/349 • Number of events 39 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	6.7% 23/342 • Number of events 24 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	4.5% 3/67 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Surgical and medical procedures Medical device implantation	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Aortic aneurysm	0.57% 2/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.88% 3/342 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Aortic arteriosclerosis	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Aortic stenosis	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	3.0% 2/67 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Arterial occlusive disease	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Deep vein thrombosis	0.86% 3/349 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.2% 4/342 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Femoral artery occlusion	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Haematoma	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Haemorrhage	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	2.0% 1/51 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Hypertensive crisis	0.57% 2/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Hypotension	0.57% 2/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.2% 4/342 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Hypovolaemic shock	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Intermittent claudication	0.57% 2/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Ischaemic limb pain	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Jugular vein thrombosis	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Orthostatic hypotension	0.57% 2/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Peripheral arterial occlusive disease	0.57% 2/349 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Peripheral embolism	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Peripheral ischaemia	0.57% 2/349 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Peripheral vascular disorder	2.3% 8/349 • Number of events 8 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.2% 4/342 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Steal syndrome	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Subclavian vein thrombosis	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Thrombophlebitis	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Vascular insufficiency	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Vasculitis	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Venous occlusion	0.29% 1/349 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/342 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Vascular disorders Venous thrombosis	0.00% 0/349 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.

Other adverse events

Other adverse events
Measure	Biventricular Pacing Arm n=349 participants at risk Subjects who were implanted with a CRT device and randomized to receive biventricular pacing	Right Ventricular Pacing Arm n=342 participants at risk Subjects who were implanted with a CRT device and randomized to receive right ventricular pacing	CRT: Not Randomized n=67 participants at risk Subjects successfully implanted with a CRT device who were not randomized	Unsuccessful Implants n=51 participants at risk Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted	No Implant Attempt n=109 participants at risk Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
Cardiac disorders Atrial fibrillation	10.9% 38/349 • Number of events 42 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	9.6% 33/342 • Number of events 36 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Cardiac disorders Cardiac failure	18.1% 63/349 • Number of events 90 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	22.5% 77/342 • Number of events 114 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	3.0% 2/67 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
General disorders Adverse drug reaction	7.2% 25/349 • Number of events 30 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	5.8% 20/342 • Number of events 23 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	2.0% 1/51 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
General disorders Chest pain	5.4% 19/349 • Number of events 22 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	7.0% 24/342 • Number of events 27 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
General disorders Fatigue	3.4% 12/349 • Number of events 13 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	5.0% 17/342 • Number of events 17 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Bronchitis	4.9% 17/349 • Number of events 20 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	6.7% 23/342 • Number of events 27 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	2.0% 1/51 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Infections and infestations Urinary tract infection	8.3% 29/349 • Number of events 41 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	6.7% 23/342 • Number of events 32 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	7.5% 5/67 • Number of events 6 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Cardiac procedure complication	1.1% 4/349 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.29% 1/342 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	7.8% 4/51 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Injury, poisoning and procedural complications Inappropriate device stimulation of tissue	15.2% 53/349 • Number of events 70 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	4.1% 14/342 • Number of events 14 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	7.5% 5/67 • Number of events 6 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	2.0% 1/51 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Metabolism and nutrition disorders Dehydration	3.4% 12/349 • Number of events 14 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	5.6% 19/342 • Number of events 22 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	4.5% 3/67 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Nervous system disorders Dizziness	3.4% 12/349 • Number of events 12 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	7.6% 26/342 • Number of events 27 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	1.5% 1/67 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/51 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.4% 19/349 • Number of events 19 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	8.5% 29/342 • Number of events 30 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/67 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	2.0% 1/51 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.	0.00% 0/109 • Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.

Additional Information

BLOCK HF Clinical Trial Leader

Medtronic CRDM Clinical

Phone: 763-526-2729

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place