Trial Outcomes & Findings for Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure (NCT NCT04452149)

Last Updated: 2026-08-26

Results Overview

The proportion of PRN medication interventions with one or more associated medication intervention related serious SAEs as adjudicated by the independent Clinical Events Committee will be evaluated. The objective is met when the point estimate for the event rate is less than or equal to 0.05 (5%).

Recruitment status

COMPLETED

Study phase

Target enrollment

826 participants

Primary outcome timeframe

From 6 weeks after installation of RAMware through the duration of follow-up for Intervention arm subjects, and from the conclusion of the 13-month randomized period through the duration of follow-up for Observation arm subjects, up to 3 years.

Results posted on

2026-08-26

Participant Flow

Subjects were enrolled over an approximately four-year period at 53 investigational sites in the U.S., with first enrollment occurring on 03-SEP-2020 and last enrollment on 29-AUG-2024. Patients were screened by the investigational site team to ensure they met all inclusion and none of the exclusion criteria prior to study enrollment. Subjects were considered enrolled when informed consent was obtained, which was required prior to any study related procedures occurring.

Enrolled subjects were implanted with a Reveal LINQ™ Insertable Cardiac Monitor (ICM) with an investigational ALLEVIATE-HF RAMware download, or received this RAMware download if enrolled with a pre-existing Reveal LINQ device. Subjects were randomized following successful RAMware download.

Participant milestones

Participant milestones
Measure	Observation Arm Subjects included in both the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes, and the Safety Set used for analysis of the secondary safety outcome. Subjects received a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download (or received the RAMware download if enrolled with a pre-existing Reveal LINQ™ device). These subjects were randomized under Clinical Investigation plan version 7 or 9, and were managed per standard of care for heart failure management without visibility to the heart failure sensor data. Subjects transitioned to the intervention arm after the conclusion of the 13-month randomized period.	Intervention Arm Subjects included in both the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes, and the Safety Set used for analysis of the secondary safety outcome. Subjects received a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download (or received the RAMware download if enrolled with a pre-existing Reveal LINQ™ device). These subjects were randomized under Clinical Investigation Plan version 7 or 9, and were managed using an integrated device diagnostic-based risk stratification algorithm combined with a clinical medication plan. The subject-specific PRN (pro re nata, or 'as needed') medication plan was prescribed by the investigator and was focused on volume management, i.e. diuretics or other volume management drugs. Subjects underwent a PRN medication intervention for acute volume management upon a "high" heart failure risk status when pre-defined criteria were met. The PRN medication intervention was facilitated by a centralized team of registered nurses over a 4-day period.	Additional Participants Included Only in Safety Set - Observation Arm Subjects included in the Safety Set used to analyze the secondary safety outcome who did not meet criteria to be included in the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes. These subjects were randomized to the observation arm under Clinical Investigation Plan (CIP) version 4 , and were therefore ineligible to be included in the Analysis Set due to not being randomized under version 7 or 9 of the CIP. Treatment description is the same as described under the Observation Arm column, with the exception that these subjects transitioned to the intervention arm after 7 months of randomized follow-up.	Additional Participants Included Only in Safety Set - Intervention Arm Subjects included in the Safety Set used to analyze the secondary safety outcome who did not meet criteria to be included in the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes. With one exception, these subjects were randomized to the intervention arm under Clinical Investigation Plan (CIP) version 4, and were therefore ineligible to be included in the Analysis Set due to not being randomized under version 7 or 9 of the CIP. Treatment description for these subjects is the same as described under the Intervention Arm column. One other subject was randomized under CIP version 7, but was ineligible to be included in the Analysis Set due to exiting before being initialized on CareLink™.	Additional Participants Included Only in Safety Set - Not Randomized Subject included in the Safety Set used to analyze the secondary safety outcome who did not meet criteria to be included in the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes. This subject was intended to be randomized under Clinical Investigation Plan (CIP) version 7, but was exited before randomization occurred.	Participants Not Included in Analyses Subjects were, with one exception, exited prior to randomization. The exception was a subject who was ineligible for the study analyses due to being randomized under Clinical Investigation Plan version 4 with a pre-existing Reveal LINQ™ device, and thus did not meet criteria for inclusion in either the Analysis Set or the Safety Set.
Overall Study STARTED	354	357	41	18	1	55
Overall Study COMPLETED	287	283	16	6	0	0
Overall Study NOT COMPLETED	67	74	25	12	1	55

Reasons for withdrawal

Reasons for withdrawal
Measure	Observation Arm Subjects included in both the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes, and the Safety Set used for analysis of the secondary safety outcome. Subjects received a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download (or received the RAMware download if enrolled with a pre-existing Reveal LINQ™ device). These subjects were randomized under Clinical Investigation plan version 7 or 9, and were managed per standard of care for heart failure management without visibility to the heart failure sensor data. Subjects transitioned to the intervention arm after the conclusion of the 13-month randomized period.	Intervention Arm Subjects included in both the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes, and the Safety Set used for analysis of the secondary safety outcome. Subjects received a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download (or received the RAMware download if enrolled with a pre-existing Reveal LINQ™ device). These subjects were randomized under Clinical Investigation Plan version 7 or 9, and were managed using an integrated device diagnostic-based risk stratification algorithm combined with a clinical medication plan. The subject-specific PRN (pro re nata, or 'as needed') medication plan was prescribed by the investigator and was focused on volume management, i.e. diuretics or other volume management drugs. Subjects underwent a PRN medication intervention for acute volume management upon a "high" heart failure risk status when pre-defined criteria were met. The PRN medication intervention was facilitated by a centralized team of registered nurses over a 4-day period.	Additional Participants Included Only in Safety Set - Observation Arm Subjects included in the Safety Set used to analyze the secondary safety outcome who did not meet criteria to be included in the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes. These subjects were randomized to the observation arm under Clinical Investigation Plan (CIP) version 4 , and were therefore ineligible to be included in the Analysis Set due to not being randomized under version 7 or 9 of the CIP. Treatment description is the same as described under the Observation Arm column, with the exception that these subjects transitioned to the intervention arm after 7 months of randomized follow-up.	Additional Participants Included Only in Safety Set - Intervention Arm Subjects included in the Safety Set used to analyze the secondary safety outcome who did not meet criteria to be included in the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes. With one exception, these subjects were randomized to the intervention arm under Clinical Investigation Plan (CIP) version 4, and were therefore ineligible to be included in the Analysis Set due to not being randomized under version 7 or 9 of the CIP. Treatment description for these subjects is the same as described under the Intervention Arm column. One other subject was randomized under CIP version 7, but was ineligible to be included in the Analysis Set due to exiting before being initialized on CareLink™.	Additional Participants Included Only in Safety Set - Not Randomized Subject included in the Safety Set used to analyze the secondary safety outcome who did not meet criteria to be included in the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes. This subject was intended to be randomized under Clinical Investigation Plan (CIP) version 7, but was exited before randomization occurred.	Participants Not Included in Analyses Subjects were, with one exception, exited prior to randomization. The exception was a subject who was ineligible for the study analyses due to being randomized under Clinical Investigation Plan version 4 with a pre-existing Reveal LINQ™ device, and thus did not meet criteria for inclusion in either the Analysis Set or the Safety Set.
Overall Study Death	17	22	9	5	0	6
Overall Study Lost to Follow-up	1	7	4	1	0	1
Overall Study Withdrawal by Subject	19	20	2	2	0	22
Overall Study Device Upgrade to CIED	29	24	8	2	0	0
Overall Study Other Reason (i.e. inability to transmit via CareLink™, patient in hospice, relocation)	1	1	1	1	0	0
Overall Study Screen Failure	0	0	0	0	1	13
Overall Study Adverse Event	0	0	1	1	0	1
Overall Study Physician Decision	0	0	0	0	0	1
Overall Study Procedure Not Attempted	0	0	0	0	0	11

Baseline Characteristics

Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Observation Arm n=354 Participants Subjects included in both the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes, and the Safety Set used for analysis of the secondary safety outcome. Subjects received a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download (or received the RAMware download if enrolled with a pre-existing Reveal LINQ™ device). These subjects were randomized under Clinical Investigation plan version 7 or 9, and were managed per standard of care for heart failure management without visibility to the heart failure sensor data. Subjects transitioned to the intervention arm after the conclusion of the 13-month randomized period.	Intervention Arm n=357 Participants Subjects included in both the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes, and the Safety Set used for analysis of the secondary safety outcome. Subjects received a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download (or received the RAMware download if enrolled with a pre-existing Reveal LINQ™ device). These subjects were randomized under Clinical Investigation Plan version 7 or 9, and were managed using an integrated device diagnostic-based risk stratification algorithm combined with a clinical medication plan. The subject-specific PRN (pro re nata, or 'as needed') medication plan was prescribed by the investigator and was focused on volume management, i.e. diuretics or other volume management drugs. Subjects underwent a PRN medication intervention for acute volume management upon a "high" heart failure risk status when pre-defined criteria were met. The PRN medication intervention was facilitated by a centralized team of registered nurses over a 4-day period.	Additional Participants Included Only in Safety Set - Observation Arm n=41 Participants Subjects included in the Safety Set used to analyze the secondary safety outcome who did not meet criteria to be included in the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes. These subjects were randomized to the observation arm under Clinical Investigation Plan (CIP) version 4 , and were therefore ineligible to be included in the Analysis Set due to not being randomized under version 7 or 9 of the CIP. Treatment description is the same as described under the Observation Arm column, with the exception that these subjects transitioned to the intervention arm after 7 months of randomized follow-up.	Additional Participants Included Only in Safety Set - Intervention Arm n=18 Participants Subjects included in the Safety Set used to analyze the secondary safety outcome who did not meet criteria to be included in the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes. With one exception, these subjects were randomized to the intervention arm under Clinical Investigation Plan (CIP) version 4, and were therefore ineligible to be included in the Analysis Set due to not being randomized under version 7 or 9 of the CIP. Treatment description for these subjects is the same as described under the Intervention Arm column. One other subject was randomized under CIP version 7, but was ineligible to be included in the Analysis Set due to exiting before being initialized on CareLink™.	Additional Participants Included Only in Safety Set - Not Randomized n=1 Participants Subject included in the Safety Set used to analyze the secondary safety outcome who did not meet criteria to be included in the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes. This subject was intended to be randomized under Clinical Investigation Plan (CIP) version 7, but was exited before randomization occurred.	Participants Not Included in Analyses n=46 Participants Subjects were, with one exception, exited prior to randomization. The exception was a subject who was ineligible for the study analyses due to being randomized under Clinical Investigation Plan version 4 with a pre-existing Reveal LINQ™ device, and thus did not meet criteria for inclusion in either the Analysis Set or the Safety Set.	Total n=817 Participants Total of all reporting groups
Age, Continuous	70.8 Years STANDARD_DEVIATION 11.7 • n=31 Participants	70.2 Years STANDARD_DEVIATION 12.2 • n=49 Participants	67.2 Years STANDARD_DEVIATION 11.7 • n=80 Participants	70.7 Years STANDARD_DEVIATION 12.2 • n=29 Participants	61.6 Years STANDARD_DEVIATION NA • n=106 Participants	72.4 Years STANDARD_DEVIATION 13.2 • n=6 Participants	70.4 Years STANDARD_DEVIATION 12.0 • n=6 Participants
Sex: Female, Male Female	155 Participants n=31 Participants	170 Participants n=49 Participants	16 Participants n=80 Participants	7 Participants n=29 Participants	0 Participants n=106 Participants	23 Participants n=6 Participants	371 Participants n=6 Participants
Sex: Female, Male Male	199 Participants n=31 Participants	187 Participants n=49 Participants	25 Participants n=80 Participants	11 Participants n=29 Participants	1 Participants n=106 Participants	23 Participants n=6 Participants	446 Participants n=6 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=31 Participants	2 Participants n=49 Participants	0 Participants n=80 Participants	0 Participants n=29 Participants	0 Participants n=106 Participants	0 Participants n=6 Participants	4 Participants n=6 Participants
Race/Ethnicity, Customized Asian	3 Participants n=31 Participants	2 Participants n=49 Participants	0 Participants n=80 Participants	0 Participants n=29 Participants	0 Participants n=106 Participants	1 Participants n=6 Participants	6 Participants n=6 Participants
Race/Ethnicity, Customized Black or African American	44 Participants n=31 Participants	33 Participants n=49 Participants	8 Participants n=80 Participants	5 Participants n=29 Participants	0 Participants n=106 Participants	7 Participants n=6 Participants	97 Participants n=6 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=31 Participants	0 Participants n=49 Participants	0 Participants n=80 Participants	0 Participants n=29 Participants	0 Participants n=106 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants
Race/Ethnicity, Customized White	297 Participants n=31 Participants	314 Participants n=49 Participants	33 Participants n=80 Participants	13 Participants n=29 Participants	1 Participants n=106 Participants	37 Participants n=6 Participants	695 Participants n=6 Participants
Race/Ethnicity, Customized Other	8 Participants n=31 Participants	6 Participants n=49 Participants	0 Participants n=80 Participants	0 Participants n=29 Participants	0 Participants n=106 Participants	0 Participants n=6 Participants	14 Participants n=6 Participants
Race/Ethnicity, Customized Not reported	0 Participants n=31 Participants	0 Participants n=49 Participants	0 Participants n=80 Participants	0 Participants n=29 Participants	0 Participants n=106 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
LVEF >= 50%	237 Participants n=31 Participants	246 Participants n=49 Participants	29 Participants n=80 Participants	13 Participants n=29 Participants	0 Participants n=106 Participants	28 Participants n=6 Participants	553 Participants n=6 Participants

PRIMARY outcome

Timeframe: From 6 weeks after installation of RAMware through the duration of follow-up for Intervention arm subjects, and from the conclusion of the 13-month randomized period through the duration of follow-up for Observation arm subjects, up to 3 years.

Population: The outcome measure is based on number of PRN medication interventions and not number of subjects with interventions nor total number of subjects in the study. To qualify for a PRN intervention a subject must have been randomized to the Intervention arm and experienced a "high" heart failure risk status during the efficacy analysis period, or been randomized to either treatment arm and experienced a "high" risk status after continuing to the post-randomization prolonged follow-up period.

Outcome measures

Outcome measures
Measure	PRN Medication Interventions n=931 Interventions PRN medication interventions performed during the eligibility period for PRN interventions, defined as from 6 weeks after installation of RAMware through end of follow-up for Intervention arm subjects, and after the conclusion of the 13-month randomized period through end of follow-up for Observation arm subjects, up to 3 years. The analysis population includes subjects in the Analysis Set (i.e. subjects who were randomized under Clinical Investigation Plan (CIP) version 7 or 9, had the investigational RAMware downloaded to their Reveal LINQ™ device, and were initialized on CareLink™).
Safety of Patient Management Pathway - Proportion of PRN Medication Interventions With Associated PRN Medication Intervention Related Serious Adverse Events (SAEs)	0.00322 Proportion of Interventions with SAEs Interval 0.00104 to 0.00987

PRIMARY outcome

Timeframe: From 6 weeks after installation of RAMware to the end of the 13-month randomized period.

Population: Includes subjects who experienced a "high" heart failure risk status during the analysis period, defined as from 6 weeks after installation of RAMware to the end of the 13-month randomized period.

The win ratio for the hierarchical composite endpoint, defined as Intervention arm wins divided by Observation arm wins, will be evaluated using the Finkelstein-Schoenfeld test. Analysis will include subjects with at least one "high" HF risk status during the analysis period (i.e. between 42 and 395 days post-randomization, to exclude the 6-weeks after the installation of RAMware and include data occurring prior to the 13-month timepoint). HF event, as adjudicated by the independent Clinical Events Committee, is defined as an event requiring invasive HF therapy (e.g. IV or subcutaneous diuretics/vasodilators/inotropes) or ultrafiltration, and includes events with or without hospitalization. The Clinical Composite Score is used as KCCQ measure. The primary efficacy objective is met when the win ratio is significantly larger than 1.0, with a p-value below 0.05.

Outcome measures

Outcome measures
Measure	PRN Medication Interventions n=426 Participants PRN medication interventions performed during the eligibility period for PRN interventions, defined as from 6 weeks after installation of RAMware through end of follow-up for Intervention arm subjects, and after the conclusion of the 13-month randomized period through end of follow-up for Observation arm subjects, up to 3 years. The analysis population includes subjects in the Analysis Set (i.e. subjects who were randomized under Clinical Investigation Plan (CIP) version 7 or 9, had the investigational RAMware downloaded to their Reveal LINQ™ device, and were initialized on CareLink™).
Efficacy of Patient Management Pathway - Hierarchical Composite of Cardiovascular Death, Heart Failure (HF) Events, Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) and Change in Six-minute Walk Test Distance	0.79 Win Ratio Interval 0.62 to 1.01

SECONDARY outcome

Timeframe: From time of Reveal LINQ™ device insertion attempt to 6 months post insertion attempt.

Population: Subjects with device insertion attempt after enrollment under any CIP version. Includes subjects in Analysis Set with insertion attempt post enrollment (698/711), plus 60 subjects with insertion attempt post enrollment who were not part of Analysis Set. Analysis was performed on a single combined group as pre-specified, since insertion occurred prior to randomization, and evaluation of safety of the Reveal LINQ™ system and procedure is not related to or influenced by randomization or study arm.

Freedom from Reveal LINQ™ system and procedure related serious adverse events (SAEs) as adjudicated by the independent Clinical Events Committee will be evaluated. The objective is met when freedom from system and procedure related SAEs at 6 months is greater than or equal to 95%.

Outcome measures

Outcome measures
Measure	PRN Medication Interventions n=758 Participants PRN medication interventions performed during the eligibility period for PRN interventions, defined as from 6 weeks after installation of RAMware through end of follow-up for Intervention arm subjects, and after the conclusion of the 13-month randomized period through end of follow-up for Observation arm subjects, up to 3 years. The analysis population includes subjects in the Analysis Set (i.e. subjects who were randomized under Clinical Investigation Plan (CIP) version 7 or 9, had the investigational RAMware downloaded to their Reveal LINQ™ device, and were initialized on CareLink™).
Safety of Reveal LINQ™ System and Procedure - Percentage of Subjects With Freedom From Experiencing System or Procedure Related Serious Adverse Events	99.5 Percentage of participants Interval 98.9 to 99.98

SECONDARY outcome

Timeframe: From 6 weeks after installation of RAMware to the end of the 13-month randomized period.

Population: Subjects who experienced a "high" heart failure risk status during the analysis period, defined as from the 6 weeks after installation of RAMware to the end of the 13-month randomized period.

The win ratio for the hierarchical composite endpoint, defined as Intervention arm wins divided by Observation arm wins, will be evaluated using the Finkelstein-Schoenfeld test. Analysis will include subjects with at least one "high" HF risk status during the analysis period (i.e. between 42 and 395 days post-randomization, to exclude the 6-weeks after the installation of RAMware and include data occurring prior to the 13-month timepoint). HF event, as adjudicated by the independent Clinical Events Committee, is defined as an event requiring invasive HF therapy (e.g. IV or subcutaneous diuretics/vasodilators/inotropes) or ultrafiltration, and includes events with or without hospitalization. The Clinical Composite Score is used as KCCQ measure. The secondary efficacy objective is met when the win ratio is significantly larger than 1.0, with a p-value below 0.05.

Outcome measures

Outcome measures
Measure	PRN Medication Interventions n=426 Participants PRN medication interventions performed during the eligibility period for PRN interventions, defined as from 6 weeks after installation of RAMware through end of follow-up for Intervention arm subjects, and after the conclusion of the 13-month randomized period through end of follow-up for Observation arm subjects, up to 3 years. The analysis population includes subjects in the Analysis Set (i.e. subjects who were randomized under Clinical Investigation Plan (CIP) version 7 or 9, had the investigational RAMware downloaded to their Reveal LINQ™ device, and were initialized on CareLink™).
Efficacy of Patient Management Pathway - Hierarchical Composite of Cardiovascular Death, HF Events, Change in KCCQ, Change in Six-minute Walk Test Distance, and Change in Device-measured Activity and Night Heart Rate	0.79 Win Ratio Interval 0.63 to 1.0

Adverse Events

Observation Arm - Analysis Period

Serious events: 218 serious events

Other events: 74 other events

Deaths: 17 deaths

Intervention Arm - Analysis Period

Serious events: 218 serious events

Other events: 91 other events

Deaths: 22 deaths

Prolonged Follow-up Post Analysis Period

Serious events: 173 serious events

Other events: 59 other events

Deaths: 16 deaths

Additional Participants Included Only in Safety Set

Serious events: 49 serious events

Other events: 25 other events

Deaths: 14 deaths

Participants Not Included in Analyses

Serious events: 11 serious events

Other events: 1 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Observation Arm - Analysis Period n=354 participants at risk Subjects received a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download (or received the RAMware download if enrolled with a pre-existing Reveal LINQ™ device). These subjects were randomized under Clinical Investigation plan version 7 or 9, and were managed per standard of care for heart failure management without visibility to the heart failure sensor data. Subjects transitioned to the intervention arm after the conclusion of the 13-month randomized period. Events are reported from randomization to 13-months post-randomization.	Intervention Arm - Analysis Period n=357 participants at risk Subjects received a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download (or received the RAMware download if enrolled with a pre-existing Reveal LINQ™ device). These subjects were randomized under Clinical Investigation Plan version 7 or 9, and were managed using an integrated device diagnostic-based risk stratification algorithm combined with a clinical medication plan. The subject-specific PRN (pro re nata, or 'as needed') medication plan was prescribed by the investigator and was focused on volume management, i.e. diuretics or other volume management drugs. Subjects underwent a PRN medication intervention for acute volume management upon a "high" heart failure risk status when pre-defined criteria were met. The PRN medication intervention was facilitated by a centralized team of registered nurses over a 4-day period. Events are reported from randomization to 13-months post-randomization.	Prolonged Follow-up Post Analysis Period n=436 participants at risk Includes the combined group of subjects who were randomized to either the Observation arm or the Intervention arm. Events are reported from the conclusion of the 13-month randomized period to end of subject participation, up to 3 years.	Additional Participants Included Only in Safety Set n=60 participants at risk Subjects included in the Safety Set used to analyze the secondary safety outcome who did not meet criteria to be included in the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes. These subjects are reported as a combined group since the secondary safety outcome was pre-specified as a non-randomized analysis, and thus randomization arms are not pertinent in this group. Most of these subjects (58/60) were ineligible to be included in the Analysis Set due to being enrolled/randomized under version 4 of the Clinical Investigation Plan (CIP). Two other subjects were enrolled and implanted under CIP version 7 or 9 but were ineligible to be included in the Analysis Set due to either exiting before being initialized on CareLink™, or exiting before randomization.	Participants Not Included in Analyses n=55 participants at risk Subjects were, with one exception, exited prior to randomization. The exception was a subject who was ineligible for the study analyses due to being enrolled under a previous version of the Clinical Investigation Plan (version 4) with a pre-existing LINQ device, and thus did not meet criteria for inclusion in either the Analysis Set or the Safety Set.
Blood and lymphatic system disorders Anaemia	2.0% 7/354 • Number of events 8 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.1% 4/357 • Number of events 7 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 8/436 • Number of events 12 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Blood and lymphatic system disorders Blood loss anaemia	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Blood and lymphatic system disorders Iron deficiency anaemia	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Blood and lymphatic system disorders Microcytic anaemia	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Blood and lymphatic system disorders Normocytic anaemia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Blood and lymphatic system disorders Spontaneous haematoma	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Acute coronary syndrome	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Acute left ventricular failure	1.1% 4/354 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.1% 4/357 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.69% 3/436 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Acute myocardial infarction	1.1% 4/354 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	2.0% 7/357 • Number of events 8 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.92% 4/436 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Acute right ventricular failure	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Angina pectoris	1.7% 6/354 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	2.0% 7/357 • Number of events 7 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.92% 4/436 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Angina unstable	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Aortic valve incompetence	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Aortic valve stenosis	0.85% 3/354 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Arrhythmia	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Atrial fibrillation	23.4% 83/354 • Number of events 114 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	21.3% 76/357 • Number of events 102 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	12.2% 53/436 • Number of events 67 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	23.3% 14/60 • Number of events 25 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Atrial flutter	2.3% 8/354 • Number of events 11 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	2.0% 7/357 • Number of events 9 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.1% 5/436 • Number of events 5 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 5 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Atrial tachycardia	1.4% 5/354 • Number of events 5 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Atrial thrombosis	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Atrioventricular block	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Atrioventricular block complete	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Atrioventricular block second degree	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Bradycardia	1.1% 4/354 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.69% 3/436 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Bundle branch block left	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Cardiac arrest	0.56% 2/354 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.1% 4/357 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	7.3% 4/55 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Cardiac failure	13.6% 48/354 • Number of events 73 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	16.2% 58/357 • Number of events 92 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	8.5% 37/436 • Number of events 54 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	16.7% 10/60 • Number of events 12 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.6% 2/55 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Cardiac failure acute	4.2% 15/354 • Number of events 19 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	5.6% 20/357 • Number of events 23 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	2.8% 12/436 • Number of events 15 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Cardiac failure chronic	0.28% 1/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.84% 3/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.69% 3/436 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Cardiac failure congestive	2.8% 10/354 • Number of events 13 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.4% 12/357 • Number of events 14 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.6% 7/436 • Number of events 9 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	8.3% 5/60 • Number of events 7 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.6% 2/55 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Cardiogenic shock	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Cardiomyopathy	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Cardiopulmonary failure	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Cardiovascular disorder	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Chronic left ventricular failure	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Chronotropic incompetence	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Coronary artery disease	2.0% 7/354 • Number of events 8 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	2.8% 10/357 • Number of events 10 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.69% 3/436 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Coronary artery stenosis	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Ischaemic cardiomyopathy	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Left ventricular failure	0.56% 2/354 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Mitral valve incompetence	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Mitral valve prolapse	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Myocardial infarction	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Myocardial ischaemia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Nodal arrhythmia	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Palpitations	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Pericardial effusion	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Pericarditis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Pericarditis constrictive	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Pulseless electrical activity	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Right ventricular failure	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Sinus arrest	1.1% 4/354 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Sinus bradycardia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Sinus node dysfunction	1.1% 4/354 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	2.0% 7/357 • Number of events 7 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.92% 4/436 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Stress cardiomyopathy	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Supraventricular tachycardia	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Tachyarrhythmia	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Tachycardia	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Tricuspid valve incompetence	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Ventricular extrasystoles	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Ventricular fibrillation	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Ventricular tachycardia	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.4% 6/436 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	5.0% 3/60 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Ear and labyrinth disorders Vertigo	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Endocrine disorders Goitre	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Endocrine disorders Thyroid mass	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Eye disorders Retinal artery occlusion	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Eye disorders Retinal detachment	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Eye disorders Visual impairment	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Abdominal hernia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Abdominal pain	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Abdominal pain upper	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Ascites	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Chronic gastrointestinal bleeding	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Constipation	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Crohn's disease	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Diverticulum	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Enteritis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Gastritis erosive	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.4% 5/354 • Number of events 5 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.92% 4/436 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	5.0% 3/60 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Gastrointestinal ulcer haemorrhage	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Haematochezia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Intestinal pseudo-obstruction	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Large intestine polyp	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Pancreatitis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Pancreatitis acute	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Rectal haemorrhage	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Small intestinal obstruction	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Umbilical hernia	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Vomiting	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Asthenia	0.85% 3/354 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Chest discomfort	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Chest pain	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.84% 3/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.92% 4/436 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Death	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.84% 3/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	6.7% 4/60 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Fatigue	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Generalised oedema	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Medical device site erosion	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Oedema	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Medical device site pain	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Non-cardiac chest pain	1.4% 5/354 • Number of events 5 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Thrombosis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Oedema peripheral	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.84% 3/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Peripheral swelling	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Hepatobiliary disorders Bile duct stone	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Prosthetic cardiac valve regurgitation	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Systemic inflammatory response syndrome	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Hepatobiliary disorders Biloma	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Hepatobiliary disorders Cholecystitis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Hepatobiliary disorders Cholelithiasis	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Hepatobiliary disorders Hepatic failure	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Hepatobiliary disorders Liver injury	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Immune system disorders Amyloidosis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Immune system disorders Hypersensitivity	0.28% 1/354 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Abdominal abscess	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Acute sinusitis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Arthritis bacterial	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Bacteraemia	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Biliary sepsis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Breast abscess	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Bronchitis	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Bronchitis viral	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Catheter site infection	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Cellulitis	1.4% 5/354 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 6/357 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.69% 3/436 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Clostridium difficile infection	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations COVID-19	2.0% 7/354 • Number of events 7 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 6/357 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	6.7% 4/60 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations COVID-19 pneumonia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Cystitis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Device related sepsis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Endocarditis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Gangrene	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Gastroenteritis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Gastroenteritis viral	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Infection	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Influenza	1.1% 4/354 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Intestinal sepsis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Localised infection	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Medical device site infection	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Metapneumovirus infection	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Oesophageal infection	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Osteomyelitis	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Osteomyelitis acute	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Parainfluenzae virus infection	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Pelvic abscess	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Pneumococcal bacteraemia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Pneumonia	5.1% 18/354 • Number of events 24 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.6% 13/357 • Number of events 16 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	2.3% 10/436 • Number of events 10 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.6% 2/55 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Pneumonia aspiration	0.56% 2/354 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.84% 3/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Pneumonia bacterial	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Pneumonia influenzal	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Pneumonia viral	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Pulmonary sepsis	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Pyelonephritis	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Sepsis	1.1% 4/354 • Number of events 5 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.69% 3/436 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Septic shock	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.84% 3/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Skin bacterial infection	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Skin candida	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Staphylococcal bacteraemia	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.1% 4/357 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Staphylococcal infection	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Streptococcal bacteraemia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Upper respiratory tract infection	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Urinary tract candidiasis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Urinary tract infection	2.3% 8/354 • Number of events 8 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	2.5% 9/357 • Number of events 13 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.69% 3/436 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Urinary tract infection staphylococcal	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Urosepsis	1.1% 4/354 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.1% 4/357 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.69% 3/436 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Wound cellulitis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Wound infection	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Ankle fracture	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Atrio-oesophageal fistula	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Fall	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.84% 3/357 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.92% 4/436 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Femoral neck fracture	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Foot fracture	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Head injury	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.84% 3/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Ligament rupture	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Procedural haemorrhage	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Skin laceration	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Investigations Anticoagulation drug level above therapeutic	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Subdural haematoma	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Investigations Anticoagulation drug level below therapeutic	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Investigations Blood pressure increased	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Investigations Cardiac stress test abnormal	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Investigations Culture urine positive	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Investigations Ejection fraction decreased	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Investigations Haemoglobin decreased	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Investigations Hepatic enzyme increased	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Dehydration	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	5.0% 3/60 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Electrolyte imbalance	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Failure to thrive	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hyperglycaemia	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hyperkalaemia	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hypervolaemia	1.7% 6/354 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.1% 11/357 • Number of events 14 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.69% 3/436 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	5.0% 3/60 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hypoglycaemia	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hypokalaemia	0.85% 3/354 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.1% 4/357 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hypomagnesaemia	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hyponatraemia	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.1% 4/357 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.69% 3/436 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Arthropathy	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Back pain	0.28% 1/354 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Groin pain	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Aphasia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cerebral haemangioma	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Cerebellar haemorrhage	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Cerebellar infarction	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Cerebral haemorrhage	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Cerebrovascular accident	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.4% 5/357 • Number of events 5 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.92% 4/436 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Cervical radiculopathy	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Dizziness	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Encephalopathy	0.56% 2/354 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.84% 3/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Haemorrhage intracranial	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Hemiparesis	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Hemiplegic migraine	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Intraventricular haemorrhage	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Ischaemic stroke	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Lacunar infarction	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Metabolic encephalopathy	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Neuropathy peripheral	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Presyncope	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Radiculopathy	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Status epilepticus	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Syncope	1.1% 4/354 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 6/357 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Thalamic infarction	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Thoracic outlet syndrome	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Transient ischaemic attack	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Product issues Device dislocation	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Product issues Device malfunction	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Psychiatric disorders Confusional state	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Psychiatric disorders Depression	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Psychiatric disorders Major depression	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Psychiatric disorders Mania	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Psychiatric disorders Mental status changes	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Renal and urinary disorders Acute kidney injury	3.1% 11/354 • Number of events 11 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	4.5% 16/357 • Number of events 17 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	2.8% 12/436 • Number of events 12 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	10.0% 6/60 • Number of events 9 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Renal and urinary disorders Calculus bladder	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Renal and urinary disorders End stage renal disease	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Renal and urinary disorders Haematuria	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Renal and urinary disorders Nephrolithiasis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Renal and urinary disorders Renal artery stenosis	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Renal and urinary disorders Renal failure	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Renal and urinary disorders Renal impairment	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Renal and urinary disorders Ureterolithiasis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Renal and urinary disorders Urinary retention	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Reproductive system and breast disorders Endometrial thickening	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Reproductive system and breast disorders Uterovaginal prolapse	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.7% 6/354 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	2.8% 10/357 • Number of events 12 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.1% 5/436 • Number of events 5 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	5.0% 3/60 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.4% 12/354 • Number of events 13 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	2.8% 10/357 • Number of events 13 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	2.3% 10/436 • Number of events 11 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	5.0% 3/60 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Cystic lung disease	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.85% 3/354 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.56% 2/354 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.28% 1/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.92% 4/436 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.85% 3/354 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.84% 3/357 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.28% 1/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Tonsillar disorder	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Tracheal mass	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Aortic aneurysm	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Aortic stenosis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Deep vein thrombosis	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Hypertension	0.85% 3/354 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Hypertensive emergency	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Hypertensive urgency	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Hypotension	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.1% 11/357 • Number of events 12 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.69% 3/436 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.6% 2/55 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Hypovolaemic shock	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Intermittent claudication	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Orthostatic hypotension	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Peripheral arterial occlusive disease	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Peripheral ischaemia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Peripheral vascular disorder	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Venous occlusion	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.

Other adverse events

Other adverse events
Measure	Observation Arm - Analysis Period n=354 participants at risk Subjects received a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download (or received the RAMware download if enrolled with a pre-existing Reveal LINQ™ device). These subjects were randomized under Clinical Investigation plan version 7 or 9, and were managed per standard of care for heart failure management without visibility to the heart failure sensor data. Subjects transitioned to the intervention arm after the conclusion of the 13-month randomized period. Events are reported from randomization to 13-months post-randomization.	Intervention Arm - Analysis Period n=357 participants at risk Subjects received a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download (or received the RAMware download if enrolled with a pre-existing Reveal LINQ™ device). These subjects were randomized under Clinical Investigation Plan version 7 or 9, and were managed using an integrated device diagnostic-based risk stratification algorithm combined with a clinical medication plan. The subject-specific PRN (pro re nata, or 'as needed') medication plan was prescribed by the investigator and was focused on volume management, i.e. diuretics or other volume management drugs. Subjects underwent a PRN medication intervention for acute volume management upon a "high" heart failure risk status when pre-defined criteria were met. The PRN medication intervention was facilitated by a centralized team of registered nurses over a 4-day period. Events are reported from randomization to 13-months post-randomization.	Prolonged Follow-up Post Analysis Period n=436 participants at risk Includes the combined group of subjects who were randomized to either the Observation arm or the Intervention arm. Events are reported from the conclusion of the 13-month randomized period to end of subject participation, up to 3 years.	Additional Participants Included Only in Safety Set n=60 participants at risk Subjects included in the Safety Set used to analyze the secondary safety outcome who did not meet criteria to be included in the Analysis Set used for analysis of the primary safety outcome and primary and secondary efficacy outcomes. These subjects are reported as a combined group since the secondary safety outcome was pre-specified as a non-randomized analysis, and thus randomization arms are not pertinent in this group. Most of these subjects (58/60) were ineligible to be included in the Analysis Set due to being enrolled/randomized under version 4 of the Clinical Investigation Plan (CIP). Two other subjects were enrolled and implanted under CIP version 7 or 9 but were ineligible to be included in the Analysis Set due to either exiting before being initialized on CareLink™, or exiting before randomization.	Participants Not Included in Analyses n=55 participants at risk Subjects were, with one exception, exited prior to randomization. The exception was a subject who was ineligible for the study analyses due to being enrolled under a previous version of the Clinical Investigation Plan (version 4) with a pre-existing LINQ device, and thus did not meet criteria for inclusion in either the Analysis Set or the Safety Set.
Blood and lymphatic system disorders Anaemia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Angina pectoris	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Angina unstable	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Arrhythmia	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Atrial fibrillation	4.5% 16/354 • Number of events 16 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	4.5% 16/357 • Number of events 16 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.4% 6/436 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	6.7% 4/60 • Number of events 5 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Atrial flutter	1.1% 4/354 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Atrioventricular block	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.1% 4/357 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Bradycardia	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.1% 4/357 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Cardiac amyloidosis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Cardiac failure	4.8% 17/354 • Number of events 19 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.9% 14/357 • Number of events 15 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 8/436 • Number of events 8 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	13.3% 8/60 • Number of events 14 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Cardiac failure acute	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Cardiac failure chronic	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Cardiac failure congestive	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Chronic left ventricular failure	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Mitral valve incompetence	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Palpitations	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.1% 4/357 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Paroxysmal atrioventricular block	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Sinus arrest	0.85% 3/354 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.84% 3/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Supraventricular tachycardia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Ventricular extrasystoles	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Cardiac disorders Ventricular tachycardia	1.1% 4/354 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Gastrointestinal disorders Nausea	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Asthenia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Chest pain	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.1% 4/357 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.69% 3/436 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.8% 1/55 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Implant site dehiscence	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Implant site pain	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Malaise	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Medical device discomfort	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Medical device pain	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Investigations Heart rate decreased	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Medical device site erosion	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Medical device site erythema	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Medical device site haemorrhage	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Medical device site pain	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Medical device site rash	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Oedema	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
General disorders and administration site conditions Oedema peripheral	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	5.0% 3/60 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Medical device site cellulitis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Infections and infestations Medical device site infection	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Incision site erythema	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Incision site haematoma	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Incision site haemorrhage	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Injury, poisoning and procedural complications Incision site pain	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Investigations Blood pressure orthostatic abnormal	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Investigations Heart rate increased	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Investigations Respiratory rate increased	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Fluid retention	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Gout	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hypervolaemia	0.85% 3/354 • Number of events 4 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hypokalaemia	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.46% 2/436 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.3% 2/60 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	5.0% 3/60 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.1% 11/357 • Number of events 15 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	2.3% 10/436 • Number of events 12 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	6.7% 4/60 • Number of events 5 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Cerebrovascular accident	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Dizziness	0.85% 3/354 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.4% 5/357 • Number of events 5 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	3.0% 13/436 • Number of events 14 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	6.7% 4/60 • Number of events 5 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Dizziness postural	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.84% 3/357 • Number of events 3 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Neuropathy peripheral	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Presyncope	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Nervous system disorders Syncope	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Product issues Device dislocation	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Product issues Device extrusion	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Product issues Device temperature issue	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Psychiatric disorders Anxiety	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Renal and urinary disorders Haematuria	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.56% 2/357 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Skin and subcutaneous tissue disorders Rash	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.28% 1/357 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Blood pressure fluctuation	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Deep vein thrombosis	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Essential hypertension	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Hypertension	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.4% 5/357 • Number of events 7 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Hypotension	1.4% 5/354 • Number of events 5 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 6/357 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.4% 6/436 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	10.0% 6/60 • Number of events 6 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Intermittent claudication	0.00% 0/354 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	1.7% 1/60 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Lymphoedema	0.28% 1/354 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/436 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.
Vascular disorders Orthostatic hypotension	0.56% 2/354 • Number of events 2 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/357 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.23% 1/436 • Number of events 1 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/60 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.	0.00% 0/55 • AEs were collected from time of informed consent through duration of study participation. Events that occurred during 13-month randomized period are reported by study arm. Events that occurred during prolonged follow-up beyond 13 months (up to 3 years) in randomized subjects are combined into one group. AEs collected through duration of participation are reported for subjects who only contributed to analysis of the secondary safety outcome, and for those who were not included in any analysis. Reportable adverse events per the Clinical Investigation Plan included PRN medication intervention related, cardiovascular related, Reveal LINQ™ system or procedure related and serious adverse events.

Additional Information

Aimee Laechelt, Clinical Research Specialist

Medtronic, Inc.

Phone: +1-800-328-2518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Trial results, if published, will be at a time determined by Medtronic and provided to Medtronic for review at least 60 days prior to submission or presentation. Institution and PI cannot independently publish, disclose, or discuss any results of or information pertaining to the Study until a multi-center publication is released. However, if that publication is not released within one year after study completion, the institution or PI may publish results pertaining to their study participation.
Publication restrictions are in place

Restriction type: OTHER