Trial Outcomes & Findings for A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis (NCT NCT00401518)

NCT ID: NCT00401518

Last Updated: 2020-09-10

Results Overview

Physical Function is measured on a scale of 1-4 points (lower values are considered a better outcome)

Recruitment status

COMPLETED

Study phase

Target enrollment

390 participants

Primary outcome timeframe

24 months

Results posted on

2020-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Non-randomized ACADIA® Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized ACADIA® Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized Instrumented PLF Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Overall Study STARTED	46	227	117
Overall Study COMPLETED	40	190	94
Overall Study NOT COMPLETED	6	37	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-randomized ACADIA® n=46 Participants Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized ACADIA® n=227 Participants Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized Instrumented PLF n=117 Participants Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis	Total n=390 Participants Total of all reporting groups
Age, Continuous	58.6 years STANDARD_DEVIATION 11.46 • n=5 Participants	61.7 years STANDARD_DEVIATION 9.82 • n=7 Participants	61.4 years STANDARD_DEVIATION 10.55 • n=5 Participants	61.2 years STANDARD_DEVIATION 10.27 • n=4 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	119 Participants n=7 Participants	55 Participants n=5 Participants	196 Participants n=4 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	108 Participants n=7 Participants	62 Participants n=5 Participants	194 Participants n=4 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	0 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	41 Participants n=5 Participants	206 Participants n=7 Participants	103 Participants n=5 Participants	350 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants	12 Participants n=7 Participants	7 Participants n=5 Participants	22 Participants n=4 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Height	67.3 inches STANDARD_DEVIATION 3.91 • n=5 Participants	66.9 inches STANDARD_DEVIATION 4.41 • n=7 Participants	67.4 inches STANDARD_DEVIATION 3.86 • n=5 Participants	67.1 inches STANDARD_DEVIATION 4.19 • n=4 Participants
Weight	190.8 pounds STANDARD_DEVIATION 41.34 • n=5 Participants	191.3 pounds STANDARD_DEVIATION 39.62 • n=7 Participants	191.2 pounds STANDARD_DEVIATION 37.38 • n=5 Participants	191.2 pounds STANDARD_DEVIATION 39.07 • n=4 Participants

PRIMARY outcome

Timeframe: 24 months

Physical Function is measured on a scale of 1-4 points (lower values are considered a better outcome)

Outcome measures

Outcome measures
Measure	Non-randomized ACADIA® n=40 Participants Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized ACADIA® n=190 Participants Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized Instrumented PLF n=94 Participants Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score	1.7 score on a scale Standard Deviation 0.71	1.6 score on a scale Standard Deviation 0.62	1.7 score on a scale Standard Deviation 0.73

PRIMARY outcome

Timeframe: 24 months

Population: One patient from the Randomized ACADIA group did not have ZCQ Symptom Severity data at 24 months

Symptom Severity is measured on a scale of 1-5 points (lower values are considered a better outcome)

Outcome measures

Outcome measures
Measure	Non-randomized ACADIA® n=40 Participants Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized ACADIA® n=189 Participants Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized Instrumented PLF n=94 Participants Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score	2.1 score on a scale Standard Deviation 0.90	2.0 score on a scale Standard Deviation 0.80	2.2 score on a scale Standard Deviation 0.98

PRIMARY outcome

Timeframe: 24 months

Population: Only patients with Neurological data at 24 months and treated with ACADIA or the control treatment were analyzed

Neurological status is based on four types of measurement parameters: muscle strength, straight leg raise, sensory function, and reflexes. Each of the four parameters will be coded as Stable or Improved OR Deteriorated. Neurological assessment scores must be stable or improved compared with the preoperative baseline to be considered "Stable or Improved" neurological status. If these scores have deteriorated as compared to the preoperative baseline, then the neurological status is considered "Deteriorated".

Outcome measures

Outcome measures
Measure	Non-randomized ACADIA® n=43 Participants Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized ACADIA® n=204 Participants Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized Instrumented PLF n=99 Participants Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Number of Participants Who Maintained or Improved in Neurological Status.	30 Participants	155 Participants	75 Participants

SECONDARY outcome

Timeframe: 24 months

The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of right leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.

Outcome measures

Outcome measures
Measure	Non-randomized ACADIA® n=40 Participants Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized ACADIA® n=190 Participants Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized Instrumented PLF n=94 Participants Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Mean Visual Analog Scale (VAS) Right Leg Pain	19.4 score on a scale Standard Deviation 28.11	13.2 score on a scale Standard Deviation 24.97	22.5 score on a scale Standard Deviation 30.80

SECONDARY outcome

Timeframe: 24 months

The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of left leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.

Outcome measures

Outcome measures
Measure	Non-randomized ACADIA® n=40 Participants Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized ACADIA® n=190 Participants Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized Instrumented PLF n=94 Participants Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Mean Visual Analog Scale (VAS) Left Leg Pain	17.5 score on a scale Standard Deviation 29.72	12.2 score on a scale Standard Deviation 24.25	16.9 score on a scale Standard Deviation 26.68

SECONDARY outcome

Timeframe: 24 months

The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of back pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.

Outcome measures

Outcome measures
Measure	Non-randomized ACADIA® n=40 Participants Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized ACADIA® n=190 Participants Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized Instrumented PLF n=94 Participants Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Mean Visual Analog Scale (VAS) Back Pain	24.7 score on a scale Standard Deviation 30.23	18.8 score on a scale Standard Deviation 25.24	23.9 score on a scale Standard Deviation 26.86

SECONDARY outcome

Timeframe: 24 months

Population: Six Non-randomized ACADIA®, 37 Randomized ACADIA® and 23 Randomized instrumented PLF did not complete the 24 month visit and thus were not analyzed.

The Oswestry Disability Index (ODI) is a commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

Outcome measures

Outcome measures
Measure	Non-randomized ACADIA® n=40 Participants Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized ACADIA® n=190 Participants Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized Instrumented PLF n=94 Participants Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline	33 Participants	151 Participants	62 Participants

Adverse Events

Non-randomized ACADIA®

Serious events: 20 serious events

Other events: 46 other events

Deaths: 2 deaths

Randomized ACADIA®

Serious events: 111 serious events

Other events: 213 other events

Deaths: 4 deaths

Randomized Instrumented PLF

Serious events: 40 serious events

Other events: 108 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Director of Clinical Affairs

Globus Medical

Phone: 610-930-1800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee To prevent premature disclosure of trade secrets or other confidential information, Investigator agrees not to present, publish, or disclose study results or information about the investigational device without the express written consent of the sponsor.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Non-randomized ACADIA® n=46 participants at risk Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized ACADIA® n=226 participants at risk Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized Instrumented PLF n=117 participants at risk Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	2.2% 5/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Cardiac disorders Cardiovascular	6.5% 3/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	6.6% 15/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	6.0% 7/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
General disorders Death	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.8% 4/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Gastrointestinal disorders Gastrointestinal	6.5% 3/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	5.3% 12/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	5.1% 6/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Infections and infestations Infection - Deep Wound	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.3% 3/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
General disorders Other	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	2.2% 5/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.7% 2/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Psychiatric disorders Psychological	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.44% 1/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
General disorders Trauma	4.3% 2/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.44% 1/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	2.6% 3/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Renal and urinary disorders Urogenital	8.7% 4/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	2.2% 5/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.7% 2/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Infections and infestations Infection - Other	4.3% 2/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	3.5% 8/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	4.3% 5/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Infections and infestations Infection - Superficial Wound	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.44% 1/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Vascular disorders Cerebrovascular	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	2.2% 5/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.85% 1/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Surgical and medical procedures Surgery - Adjacent Level	2.2% 1/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	4.4% 10/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Skin and subcutaneous tissue disorders Wound Issue	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.44% 1/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Respiratory, thoracic and mediastinal disorders Respiratory	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.8% 4/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	4.3% 5/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
General disorders Vertebral Fracture	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.44% 1/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Pain-Neck and/or Upper Extremity	2.2% 1/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.8% 4/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	2.6% 3/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Pain - Back	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.3% 3/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.85% 1/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Pain-Back and Lower Extremities	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.88% 2/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Pain Lower Extremities	4.3% 2/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	5.8% 13/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	6.8% 8/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Pain - Hip	2.2% 1/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	4.9% 11/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.7% 2/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Musculoskeletal	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.88% 2/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Surgical and medical procedures Surgery - Index Level	15.2% 7/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	15.5% 35/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	11.1% 13/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Surgical and medical procedures Surgery - Other (Non-Lumbar)	2.2% 1/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.44% 1/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Surgical and medical procedures Surgery - Other Lumbar	2.2% 1/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.85% 1/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Nervous system disorders Dural Tear	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.88% 2/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.85% 1/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Nervous system disorders Neurological Focal Lumbar	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.44% 1/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
General disorders Radiographic	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.44% 1/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Immune system disorders Metal Allergy	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.44% 1/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.

Other adverse events
Measure	Non-randomized ACADIA® n=46 participants at risk Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized ACADIA® n=226 participants at risk Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized Instrumented PLF n=117 participants at risk Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	4.3% 2/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.88% 2/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	3.4% 4/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Cardiac disorders Cardiovascular	21.7% 10/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	9.3% 21/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	11.1% 13/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Nervous system disorders Dysesthesia - Upper Extremities	2.2% 1/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.85% 1/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Gastrointestinal disorders Gastrointestinal	19.6% 9/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	14.2% 32/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	7.7% 9/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
General disorders Headache	2.2% 1/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.3% 3/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
General disorders Other	43.5% 20/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	18.6% 42/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	20.5% 24/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
General disorders Pain - Other	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	2.2% 5/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.7% 2/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Psychiatric disorders Psychological	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	3.5% 8/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.85% 1/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
General disorders Trauma	23.9% 11/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	18.6% 42/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	22.2% 26/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Renal and urinary disorders Urogenital	4.3% 2/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	9.3% 21/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	4.3% 5/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Nervous system disorders Dysesthesia - Lower Extremities	4.3% 2/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.88% 2/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.7% 2/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Infections and infestations Infection - Superficial Wound	2.2% 1/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.8% 4/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.7% 2/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Infections and infestations Infection - Other	19.6% 9/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	10.2% 23/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	14.5% 17/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Vascular disorders Cerebrovascular	2.2% 1/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.3% 3/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Surgical and medical procedures Surgery - Adjacent Level	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.3% 3/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.7% 2/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Skin and subcutaneous tissue disorders Wound Issue	2.2% 1/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	2.2% 5/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	3.4% 4/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Respiratory, thoracic and mediastinal disorders Respiratory	4.3% 2/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	7.1% 16/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	6.0% 7/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
General disorders Spinous Process Fracture	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.44% 1/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
General disorders Vertebral Fracture	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.88% 2/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.85% 1/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.8% 4/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.85% 1/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Pain-Neck and/or Upper Extremity	19.6% 9/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	13.3% 30/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	18.8% 22/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Pain - Back	41.3% 19/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	31.9% 72/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	23.1% 27/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Pain-Back and Lower Extremities	13.0% 6/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	15.0% 34/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	14.5% 17/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Pain - Back and Hip	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.3% 3/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.85% 1/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Pain Lower Extremities	39.1% 18/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	30.1% 68/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	32.5% 38/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Pain - Hip	26.1% 12/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	12.4% 28/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	12.0% 14/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Musculoskeletal	10.9% 5/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	8.0% 18/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	11.1% 13/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Nervous system disorders Neurological Systemic	2.2% 1/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.8% 4/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.85% 1/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Nervous system disorders Dysesthesia - Other	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.3% 3/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.85% 1/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Pain-Back and Lower Extremities with Dysesthesia	4.3% 2/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	4.4% 10/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.7% 2/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Pain-Back with Dysesthesia	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.88% 2/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.85% 1/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Musculoskeletal and connective tissue disorders Pain Lower Extremities with Dysesthesia	6.5% 3/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	3.5% 8/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	4.3% 5/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Surgical and medical procedures Surgery-Index Level	4.3% 2/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	2.7% 6/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.85% 1/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Surgical and medical procedures Surgery - Other (Non-Lumbar)	2.2% 1/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.88% 2/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
General disorders Weakness	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.88% 2/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	3.4% 4/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Nervous system disorders Paresthesia - Upper Extremities	8.7% 4/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	3.1% 7/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	3.4% 4/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Nervous system disorders Paresthesia - Lower Extremities	8.7% 4/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	9.7% 22/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	8.5% 10/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Nervous system disorders Paresthesia - Other	2.2% 1/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Hepatobiliary disorders Pseudoarthrosis	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	1.7% 2/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Surgical and medical procedures Surgery - Other Lumbar	0.00% 0/46 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.44% 1/226 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.	0.00% 0/117 • 24 months The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.