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In an online randomized trial of Safety in Dementia with national recruitment and longitudinal follow-up, we will recruit informal caregivers of community-dwelling adults with dementia who have firearm access.
Aim 1: To test the efficacy of Safety in Dementia (SiD) on firearm safety decision quality and behaviors, among a national sample of informal caregivers of community-dwelling people with dementia and firearm access (n=500).
Aim 2: To compare varied methods in reaching informal caregivers. Aim 3: To explore stakeholder longitudinal experiences with SiD and firearm-related decisions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety in Dementia | Experimental | Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. |
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| Web control | Active Comparator | The control group will view National Institute on Aging Home Safety Checklist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safety in Dementia | Behavioral | Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. The control group will view national Institute on Aging Home Safety Checklist. |
| Measure | Description | Time Frame |
|---|---|---|
| Preparation for Decision Making | The Preparation for Decision Making Scale assesses perception of how useful a decision aid is in preparing for subsequent decision-making. Scores range from 1-5, calculated from the sum of 10 constructs (each ranging from 1, 'not at all' to 5, 'a great deal'). The total score is calculated by first summing the 10 items and dividing by 10 to find an average item response score. Then, we subtract 1 from the summed score and multiply this by 25 to convert the final score to a 0-100 scale with higher scores indicating higher perceived levels of preparation for decision making (higher = better). The scale has high test reliability (0.944) and discriminates significantly between different decision support interventions. | During baseline assessment (specifically, after receiving randomization allocation), 2 weeks, 2 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Decision Self-Efficacy | The Decision Self-Efficacy Scale measures confidence in ability to make decisions; transformed scores range from 0 (extremely low, worst outcome) to 100 (extremely high self-efficacy, best outcome). | baseline/pre-intervention, 2 weeks, 2 months, 6 months |
| Number of People With Dementia Who Retained Firearm Access |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39531391 | Derived | Betz ME, Portz J, Knoepke C, Ranney ML, Fischer SM, Peterson RA, Johnson RL, Omeragic F, Castaneda M, Greenway E, Matlock D. The Effect of the "Safety in Dementia" Online Tool to Assist Decision Making for Caregivers of Persons With Dementia and Access to Firearms : A Randomized Trial. Ann Intern Med. 2024 Dec;177(12):1630-1640. doi: 10.7326/ANNALS-24-00763. Epub 2024 Oct 22. | |
| 36719721 |
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Of N = 522 eligible participants who consented and were sent the survey invitation, N = 22 did not begin the survey or stopped completing the survey before randomization and viewing of the control or Safe at Home information. Therefore, the sample is comprise of N = 500 individuals who were enrolled and randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Web Control | The control group will view National Institute on Aging Home Safety Checklist. Safety in Dementia: Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. The control group will view national Institute on Aging Home Safety Checklist. |
| FG001 | Safety in Dementia | Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. Safety in Dementia: Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. The control group will view national Institute on Aging Home Safety Checklist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 2-week Follow-up |
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| 2-month Follow-up |
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| 6-month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Web Control | The control group will view National Institute on Aging Home Safety Checklist. Safety in Dementia: Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. The control group will view national Institute on Aging Home Safety Checklist. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | N = 13 participants were missing age responses at baseline (N = 5 Safety in Dementia/Safe at Home, N = 8 control). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Preparation for Decision Making | The Preparation for Decision Making Scale assesses perception of how useful a decision aid is in preparing for subsequent decision-making. Scores range from 1-5, calculated from the sum of 10 constructs (each ranging from 1, 'not at all' to 5, 'a great deal'). The total score is calculated by first summing the 10 items and dividing by 10 to find an average item response score. Then, we subtract 1 from the summed score and multiply this by 25 to convert the final score to a 0-100 scale with higher scores indicating higher perceived levels of preparation for decision making (higher = better). The scale has high test reliability (0.944) and discriminates significantly between different decision support interventions. | N = 492 of 500 total participants have a preparation for decision making total score at at least one time point (baseline, two week, two month, and/or six month). | Posted | Mean | Standard Deviation | score on a scale | During baseline assessment (specifically, after receiving randomization allocation), 2 weeks, 2 months, 6 months |
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Adverse event data were collected from baseline through the 6 month follow-up (6 month total time period).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Web Control | The control group will view National Institute on Aging Home Safety Checklist. Safety in Dementia: Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. The control group will view national Institute on Aging Home Safety Checklist. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide ideation or attempt in caregiver or individual with dementia | Social circumstances | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any negative verbal interaction between caregiver and person with dementia from intervention | Social circumstances | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emmy Betz | University of Colorado Anschutz Medical Campus | 720-848-9111 | marian.betz@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 6, 2024 | Sep 23, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2024 | Sep 23, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D013405 | Suicide |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012449 | Safety |
| ID | Term |
|---|---|
| D000056 | Accident Prevention |
| D000059 | Accidents |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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Firearm access for the person with ADRD will be assessed with scales we have used in prior work, allowing nuanced (but efficient) description of firearm access (on a scale ranging from access to multiple loaded firearms to no access to any firearms). For reporting and analysis, we will use binary categorization (caregiver reports that person with dementia still has access to 1+ firearm [1] versus person with dementia no longer has access to any firearms [0]) |
| 2 weeks, 2 months, 6 months |
| Number of Participants Who Took Action to Reduce Firearm Access for Person With Dementia | At each time point, participants self-reported if they have taken any steps to reduce firearm access for the person with dementia. Nine response options associated with this question are used to calculate this binary outcome (1+ actions taken versus no action taken). If they selected 'yes' to any of the following options, their outcome was '1+ action taken' (1); if they selected 'no' to all, their outcome was 'no action taken' (0). The nine response options were: (1) used a/more locking devices, (2) used a/more locking safes or gun lockboxes, (3) gave a/more guns to a trusted family member for temporary safekeeping, (4) gave a/more guns to a trusted friend for temporary safekeeping, (5) stored a/more guns at a store or range that has firearm storage, (6) stored a/more guns at a law enforcement agency temporarily, (7) gave a/multiple guns to law enforcement permanently, (8) sold, gave or transferred a/multiple guns to family or friends, and (9) sold a/multiple guns to the public. | Baseline, 2 weeks, 2 months, 6 months |
| Firearm Injury | We will assess injuries involving the person with ADRD and a firearm. Participants will be asked about any such incidents in the prior year (baseline) or since enrollment (follow-up) and a brief description. | baseline/pre-intervention, 2 weeks, 2 months, 6 months |
| Caregiver Burden | The short-form Zarit Burden Interview has scores ranging from 0-48, calculated from 12 items (measured on a 5-point scale from 0, never to 4, nearly always); scores range from 0 to 12 with higher scores reflecting higher burden. | 2 weeks |
| Positive Aspects of Caregiving | The Positive Aspects of Caregiving Scale has scores ranging from 0-36, calculated from the sum of 9 items (measured on a 5-point scale ranging from 0, disagree a lot, to 4, agree a lot, on statements such as feel more useful), with higher scores indicating more positive caregiving experiences. | 2 weeks |
| Derived |
| McCarthy V, Portz J, Fischer SM, Greenway E, Johnson RL, Knoepke CE, Matlock DD, Omeragic F, Peterson RA, Ranney ML, Betz ME. A Web-Based Decision Aid for Caregivers of Persons With Dementia With Firearm Access (Safe at Home Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 31;12:e43702. doi: 10.2196/43702. |
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| BG001 | Safety in Dementia | Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. Safety in Dementia: Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. The control group will view national Institute on Aging Home Safety Checklist. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Age, Continuous | N = 13 participants were missing age responses at baseline (N = 8 control, N = 5 Safe at Home). | Mean | Standard Deviation | years |
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| Sex: Female, Male | N = 15 participants' responses were missing to this question (N = 8 control, N = 7 Safe at Home). | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Preparation for decision-making | The Preparation for Decision Making Scale assesses perception of how useful a decision aid is in preparing for subsequent decision-making. Scores range from 1-5, calculated from the sum of 10 constructs (each ranging from 1, 'not at all' to 5, 'a great deal'). The total score is calculated by first summing the 10 items and dividing by 10 to find an average item response score. Then, we subtract 1 from the summed score and multiply this by 25 to convert the final score to a 0-100 scale with higher scores indicating higher perceived levels of preparation for decision making (higher = better). | This outcome was measured at baseline post-randomization (post-intervention), not before randomization. Participants were required to respond to all variable components of the scale to have their outcome calculated, so N = 33 participants' preparation for decision-making scale scores could not be calculated. | Mean | Standard Deviation | units on a scale |
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| OG000 | Web Control | The control group will view National Institute on Aging Home Safety Checklist. Safety in Dementia: Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. The control group will view national Institute on Aging Home Safety Checklist. |
| OG001 | Safety in Dementia | Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. Safety in Dementia: Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. The control group will view national Institute on Aging Home Safety Checklist. |
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| Secondary | Decision Self-Efficacy | The Decision Self-Efficacy Scale measures confidence in ability to make decisions; transformed scores range from 0 (extremely low, worst outcome) to 100 (extremely high self-efficacy, best outcome). | N = 496 of 500 participants had sufficient data to calculate decision self-efficacy at at least one time point when it was measured (baseline, 2 week, 2 month, and/or six month). | Posted | Mean | Standard Deviation | score on a scale | baseline/pre-intervention, 2 weeks, 2 months, 6 months |
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| Secondary | Number of People With Dementia Who Retained Firearm Access | Firearm access for the person with ADRD will be assessed with scales we have used in prior work, allowing nuanced (but efficient) description of firearm access (on a scale ranging from access to multiple loaded firearms to no access to any firearms). For reporting and analysis, we will use binary categorization (caregiver reports that person with dementia still has access to 1+ firearm [1] versus person with dementia no longer has access to any firearms [0]) | N = 489 of 500 participants have at least one follow-up measure of person with dementia (PWD) firearm access. | Posted | Count of Participants | Participants | 2 weeks, 2 months, 6 months |
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| Secondary | Number of Participants Who Took Action to Reduce Firearm Access for Person With Dementia | At each time point, participants self-reported if they have taken any steps to reduce firearm access for the person with dementia. Nine response options associated with this question are used to calculate this binary outcome (1+ actions taken versus no action taken). If they selected 'yes' to any of the following options, their outcome was '1+ action taken' (1); if they selected 'no' to all, their outcome was 'no action taken' (0). The nine response options were: (1) used a/more locking devices, (2) used a/more locking safes or gun lockboxes, (3) gave a/more guns to a trusted family member for temporary safekeeping, (4) gave a/more guns to a trusted friend for temporary safekeeping, (5) stored a/more guns at a store or range that has firearm storage, (6) stored a/more guns at a law enforcement agency temporarily, (7) gave a/multiple guns to law enforcement permanently, (8) sold, gave or transferred a/multiple guns to family or friends, and (9) sold a/multiple guns to the public. | N = 497 of 500 participants reported on actions to reduce firearm access at at least one time point (baseline, 2 week follow-up, 2 month follow-up, and/or 6 month follow-up). | Posted | Count of Participants | Participants | Baseline, 2 weeks, 2 months, 6 months |
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| Secondary | Firearm Injury | We will assess injuries involving the person with ADRD and a firearm. Participants will be asked about any such incidents in the prior year (baseline) or since enrollment (follow-up) and a brief description. | N = 500 participants had data at at least one time point; missing responses at later time points are due to missing visits, withdrawn participants, or participants choosing to skip this question. | Posted | Count of Participants | Participants | baseline/pre-intervention, 2 weeks, 2 months, 6 months |
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| Secondary | Caregiver Burden | The short-form Zarit Burden Interview has scores ranging from 0-48, calculated from 12 items (measured on a 5-point scale from 0, never to 4, nearly always); scores range from 0 to 12 with higher scores reflecting higher burden. | This scale was measured at 2 week follow-up, so missing values are due to missed 2 week follow-up visits or participants skipping questions on this scale. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
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| Secondary | Positive Aspects of Caregiving | The Positive Aspects of Caregiving Scale has scores ranging from 0-36, calculated from the sum of 9 items (measured on a 5-point scale ranging from 0, disagree a lot, to 4, agree a lot, on statements such as feel more useful), with higher scores indicating more positive caregiving experiences. | N = 461 participants had sufficient data at 2 week follow-up to calculate Positive Aspects of Caregiving; missing data is due to missed 2 week follow-up visits or participants skipping questions on this scale. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
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| 0 |
| 249 |
| 9 |
| 249 |
| 36 |
| 249 |
| EG001 | Safety in Dementia | Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. Safety in Dementia: Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. The control group will view national Institute on Aging Home Safety Checklist. | 0 | 251 | 11 | 251 | 31 | 251 |
| Any negative physical interaction between caregiver and person with dementia from intervention | Social circumstances | Non-systematic Assessment |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Unknown or Not Reported |
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| 2 week follow-up |
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| 2 month follow-up |
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| 6 month follow-up |
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| 2 month follow-up |
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| 6 month follow-up |
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| 2 week follow-up |
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| 2 month follow-up |
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| 6 month follow-up |
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| 2 week follow-up |
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| 2 month follow-up |
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| 6 month follow-up |
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