Trial Outcomes & Findings for Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia (NCT NCT01426425)

Last Updated: 2025-02-13

Results Overview

Subjects must have met both of the following acute and chronic conditions to be considered a chronic effectiveness (treatment) success: * Acute Success: The inability to induce more than one echo beat by the same pacing maneuvers that induced AVNRT before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the study cryoablation procedure assessment. * Chronic Success: Lack of documented recurrence of clinical AVNRT during the 6-month follow-up period after the study cryoablation procedure.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

572 participants

Primary outcome timeframe

6 months

Results posted on

2025-02-13

Participant Flow

Thirty-seven (37) centers (8 in Canada, 29 in the US) confirmed participation in the study, with enrollments having occurred at 34 of those centers. First study enrollment occurred on 14-MAY-2012 and the last enrollment occurred on 25-FEB-2015.

Participant milestones

Participant milestones
Measure	All Participants All subjects enrolled into the study.
Overall Study STARTED	572
Overall Study EP Study	550
Overall Study Intent to Treat	399
Overall Study COMPLETED	397
Overall Study NOT COMPLETED	175

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants All subjects enrolled into the study.
Overall Study Exited prior to EP study	22
Overall Study Inclusion/exclusion criteria not met	151
Overall Study Met inclusion/exclusion, not treated	2

Baseline Characteristics

Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	mITT Set n=397 Participants The modified intent-to-treat (mITT) set.
Age, Continuous	52.6 years STANDARD_DEVIATION 13.9 • n=99 Participants
Sex: Female, Male Female	279 Participants n=99 Participants
Sex: Female, Male Male	118 Participants n=99 Participants
Race/Ethnicity, Customized Subject/physician chose not to provide information	10 Participants n=99 Participants
Race/Ethnicity, Customized Not reportable per local laws or regulations	0 Participants n=99 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=99 Participants
Race/Ethnicity, Customized Asian	10 Participants n=99 Participants
Race/Ethnicity, Customized Black or African American	16 Participants n=99 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=99 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=99 Participants
Race/Ethnicity, Customized White or Caucasian	353 Participants n=99 Participants
Race/Ethnicity, Customized Two or more races	1 Participants n=99 Participants
Race/Ethnicity, Customized Other race	2 Participants n=99 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The modified intent-to-treat (mITT) set consists of subjects who signed the ICY-AVNRT consent form and met all Pre-EP and Post-EP study inclusion and no exclusion criteria who had a Freezor Xtra Cardiac Cryoablation Catheter inserted into the vasculature for the purpose of the ICY-AVNRT study.

Outcome measures

Outcome measures
Measure	mITT Set n=397 Participants The modified intent-to-treat (mITT) set.
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach. Chronic effectiveness success	368 Participants
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach. Chronic effectiveness failure	29 Participants

PRIMARY outcome

Timeframe: 6 Months

Subjects who had at least one safety event during or after their cryoablation procedure or through 6 months of follow-up are considered a primary (chronic) safety failure. A safety event is defined as the occurrence of any adverse event that is adjudicated by the AE Adjudication Committee as being serious and study ablation procedure-related and/or Freezor Xtra Catheter related that: 1) Resulted in death, 2) Resulted in a life-threatening illness or injury, 3) Resulted in permanent impairment of a body function or permanent damage to a body structure, 4) Necessitated significant intervention, such as major surgery or even intravenous medical therapy (e.g., vasopressors), to prevent permanent impairment of a body function or permanent damage to a body structure, or 5) Required in-patient hospitalization or a prolongation of an existing hospital stay.

Outcome measures

Outcome measures
Measure	mITT Set n=397 Participants The modified intent-to-treat (mITT) set.
Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach. Chronic safety failure	4 Participants
Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach. Chronic safety success	393 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: The 378 mITT subjects who had acute procedural success with cryoablation for the treatment of AVNRT are included in this analysis.

If there was no documented evidence of AVNRT recurrence in the post-procedure 6-month follow-up period, the subject is counted as a chronic effectiveness success. The AE Adjudication Committee adjudication of AVNRT recurrence is used to classify subjects for this endpoint.

Outcome measures

Outcome measures
Measure	mITT Set n=378 Participants The modified intent-to-treat (mITT) set.
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success. Chronic effectiveness success	368 Participants
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success. Chronic effectiveness failure	10 Participants

Adverse Events

mITT Set

Serious events: 30 serious events

Other events: 197 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	mITT Set n=397 participants at risk Subjects in the modified intent-to-treat (mITT) set.
Cardiac disorders Acute myocardial infarction	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Angina pectoris	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Atrial fibrillation	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Cardiac tamponade	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Palpitations	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Tachycardia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Ear and labyrinth disorders Vertigo	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Gastritis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
General disorders Chest pain	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
General disorders Device difficult to use	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
General disorders Non-cardiac chest pain	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Bronchitis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Pneumonia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Pyelonephritis	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Femur fracture	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Incision site haemorrhage	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Metabolism and nutrition disorders Hyperglycaemia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Arthralgia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Arthrofibrosis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Retrognathia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Nervous system disorders Syncope	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Reproductive system and breast disorders Menometrorrhagia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Reproductive system and breast disorders Pelvic prolapse	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.

Other adverse events

Other adverse events
Measure	mITT Set n=397 participants at risk Subjects in the modified intent-to-treat (mITT) set.
Blood and lymphatic system disorders Lymphadenopathy	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Arrhythmia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Atrial fibrillation	2.3% 9/397 • Number of events 12 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Atrial flutter	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Atrial tachycardia	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Atrioventricular block complete	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Atrioventricular block first degree	1.5% 6/397 • Number of events 6 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Atrioventricular block second degree	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Bundle branch block right	2.8% 11/397 • Number of events 11 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Cardiac flutter	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Junctional ectopic tachycardia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Myocardial infarction	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Palpitations	10.8% 43/397 • Number of events 55 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Sinus tachycardia	1.8% 7/397 • Number of events 7 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Supraventricular extrasystoles	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Supraventricular tachycardia	5.5% 22/397 • Number of events 27 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Tachycardia	1.8% 7/397 • Number of events 7 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Ventricular extrasystoles	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Cardiac disorders Ventricular tachycardia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Congenital, familial and genetic disorders Atrial septal defect	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Congenital, familial and genetic disorders Hydrocele	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Congenital, familial and genetic disorders Laryngocele	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Ear and labyrinth disorders Vertigo	1.0% 4/397 • Number of events 4 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Endocrine disorders Hypothyroidism	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Eye disorders Cataract	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Eye disorders Conjunctival haemorrhage	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Eye disorders Conjunctivitis allergic	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Eye disorders Keratitis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Abdominal discomfort	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Abdominal pain	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Abdominal pain upper	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Cheilitis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Colitis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Constipation	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Crohn's disease	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Diarrhoea	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Dyspepsia	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Flatulence	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Gastritis	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Gastrointestinal inflammation	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Haemorrhoids	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Irritable bowel syndrome	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Nausea	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Rectal haemorrhage	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Toothache	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Gastrointestinal disorders Vomiting	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
General disorders Adverse drug reaction	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
General disorders Chest discomfort	1.5% 6/397 • Number of events 8 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
General disorders Chest pain	4.5% 18/397 • Number of events 19 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
General disorders Fatigue	1.0% 4/397 • Number of events 4 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
General disorders Gait disturbance	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
General disorders Malaise	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
General disorders Non-cardiac chest pain	1.0% 4/397 • Number of events 4 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
General disorders Oedema peripheral	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
General disorders Pain	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
General disorders Polyp	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Immune system disorders Hypersensitivity	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Acute sinusitis	1.0% 4/397 • Number of events 8 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Bacterial vaginosis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Breast abscess	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Bronchitis	2.3% 9/397 • Number of events 9 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Cellulitis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Conjunctivitis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Furuncle	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Gastroenteritis	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Herpes zoster	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Hordeolum	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Influenza	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Nasopharyngitis	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Pharyngitis	1.3% 5/397 • Number of events 5 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Pharyngitis streptococcal	0.76% 3/397 • Number of events 4 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Pneumonia	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Respiratory tract infection	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Sinusitis	1.3% 5/397 • Number of events 6 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Skin candida	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Upper respiratory tract infection	1.8% 7/397 • Number of events 9 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Urinary tract infection	1.5% 6/397 • Number of events 9 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Vaginal infection	0.25% 1/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Infections and infestations Vulvovaginal candidiasis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Animal scratch	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Ankle fracture	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Concussion	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Contusion	1.3% 5/397 • Number of events 5 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Fall	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Hand fracture	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Head injury	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Incision site pain	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Incisional hernia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Joint dislocation	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Laceration	1.3% 5/397 • Number of events 5 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Ligament sprain	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Meniscus injury	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Muscle strain	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Rib fracture	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Road traffic accident	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Injury, poisoning and procedural complications Wrist fracture	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Investigations Blood cholesterol increased	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Investigations Blood iron decreased	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Investigations Blood pressure increased	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Investigations Heart rate increased	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Investigations Heart rate irregular	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Investigations Hepatitis B antibody positive	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Investigations Liver function test abnormal	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Investigations Sinus rhythm	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Metabolism and nutrition disorders Dehydration	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Metabolism and nutrition disorders Diabetes mellitus	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Metabolism and nutrition disorders Dyslipidaemia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Metabolism and nutrition disorders Gout	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Metabolism and nutrition disorders Hypercholesterolaemia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Metabolism and nutrition disorders Hypokalaemia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Metabolism and nutrition disorders Zinc deficiency	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Arthralgia	2.0% 8/397 • Number of events 9 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Arthritis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Axillary mass	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Back pain	1.3% 5/397 • Number of events 5 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Bursitis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Costochondritis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Foot deformity	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Groin pain	1.5% 6/397 • Number of events 6 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Joint hyperextension	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Joint lock	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Muscle spasms	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.5% 6/397 • Number of events 6 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Myalgia	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Neck pain	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Osteopenia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Pain in extremity	1.8% 7/397 • Number of events 7 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Musculoskeletal and connective tissue disorders Tendonitis	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.50% 2/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Nervous system disorders Carotid artery stenosis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Nervous system disorders Carpal tunnel syndrome	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Nervous system disorders Dizziness	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Nervous system disorders Headache	2.0% 8/397 • Number of events 8 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Nervous system disorders Loss of consciousness	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Nervous system disorders Migraine	0.76% 3/397 • Number of events 6 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Nervous system disorders Paraesthesia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Nervous system disorders Presyncope	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Nervous system disorders Radiculopathy	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Nervous system disorders Restless legs syndrome	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Nervous system disorders Syncope	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Psychiatric disorders Anxiety	1.5% 6/397 • Number of events 6 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Psychiatric disorders Bipolar disorder	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Psychiatric disorders Depression	1.0% 4/397 • Number of events 4 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Psychiatric disorders Insomnia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Psychiatric disorders Intentional self-injury	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Renal and urinary disorders Bladder neck obstruction	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Renal and urinary disorders Dysuria	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Renal and urinary disorders Haematuria	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Renal and urinary disorders Nephrolithiasis	0.25% 1/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Renal and urinary disorders Renal failure	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Renal and urinary disorders Urinary incontinence	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Renal and urinary disorders Urinary retention	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Reproductive system and breast disorders Atrophic vulvovaginitis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Reproductive system and breast disorders Breast pain	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Reproductive system and breast disorders Cervical dysplasia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Reproductive system and breast disorders Cystocele	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Reproductive system and breast disorders Dysmenorrhoea	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Reproductive system and breast disorders Menorrhagia	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Reproductive system and breast disorders Uterine haemorrhage	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Reproductive system and breast disorders Vaginal discharge	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Respiratory, thoracic and mediastinal disorders Cough	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.8% 7/397 • Number of events 7 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.76% 3/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.50% 2/397 • Number of events 2 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Skin and subcutaneous tissue disorders Actinic keratosis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Skin and subcutaneous tissue disorders Dermal cyst	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Skin and subcutaneous tissue disorders Dermatitis contact	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Skin and subcutaneous tissue disorders Ecchymosis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Skin and subcutaneous tissue disorders Eczema	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Skin and subcutaneous tissue disorders Madarosis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Skin and subcutaneous tissue disorders Psoriasis	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Skin and subcutaneous tissue disorders Rosacea	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Vascular disorders Arteriovenous fistula	0.25% 1/397 • Number of events 1 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Vascular disorders Haematoma	0.50% 2/397 • Number of events 3 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.
Vascular disorders Hypertension	1.3% 5/397 • Number of events 5 • Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015). Adverse event information was provided by the investigators. All adverse events were reviewed and adjudicated by an independent (i.e., non-Medtronic) Adverse Events Adjudication Committee as serious or non-serious. Adverse events terms were coded using MedDRA 18.0 by Medtronic safety specialists.

Additional Information

Jo Krueger, Senior Clinical Research Specialist

Medtronic

Phone: 7635261551

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In most cases, the contract allows the principal investigator to publish their data per the publication strategy/Clinical Investigational Plan following Medtronic's review for (a) disclosure of confidential information ("CI"), (b) technical correctness and (c) selection and order of publications by the publications committee. Any such CI and/or item identified as not technically correct is deleted prior to publication/presentation. Medtronic may not otherwise interfere with the publication.
Publication restrictions are in place

Restriction type: OTHER