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The study is designed to demonstrate that the use of OviTex® 1S material for a ventral hernia repair leads to the same or a lower percentage of early post-operative complications and true hernia recurrences when compared to other types of available meshes. 100 subjects will be included from 5-7 participating investigator sites. Within 30 days prior to the hernia repair surgery, a baseline visit will be performed during which the patient's eligibility for the study will be evaluated. The surgical technique used for the repair will be determined by the investigator/surgeon. Additional study data will be collected during the hospital stay, 30 and 90 days post-operatively and 12 and 24 months post-operatively. At the follow up visits, the surgical site will be evaluated by the surgeon, both the surgeon and patient will be asked to rate their satisfaction with the repair and the subject will be asked to complete two Quality of Life questionnaires.
The study is intended to evaluate the post-operative complications and re-herniations following the use of OviTex® Permanent 1S reinforced bioscaffold in subjects with ventral hernias. The study is designed to mirror surgical standard of care for ventral hernia intervention, with the exception of asking for subjects to return for evaluation at longer time points post-surgery than is typical for standard care. A baseline visit will be performed for patients who are identified for and provide informed consent to participate in the study. During this visit, a review of medical history, a physical exam and assessment of the hernia site will be performed. The potential subject will also be asked to complete two quality of life surveys; one that is disease specific and one that is a standard method of health assessment. On the day of surgery, the ventral hernia will be repaired with the use of OviTex® 1S reinforced bioscaffold. Perioperative data will be collected and the surgeon will provide an assessment of the product's handling qualities. During the course of the hospital stay, the subject will be assessed for incidence of early post-operative surgical site wound events and complications, all necessary medical interventions and/or re-operations. On the day of discharge, surgical site occurrences or wound related events noted at the hernia repair site and the occurrence of other post-operative complications will be assessed.
The Day 30 and Day 90 visits will have a visit window of +/- 2 weeks. At these visits, the incidence of late surgical site occurrences or wound related events noted at the hernia repair site will be assessed. If hernia recurrence is suspected, it will be confirmed via diagnostic imaging with a CT scan. The occurrence of other late post-operative complications will also be assessed. The subjects will be asked to complete the same disease specific questionnaire and the same health assessment questionnaire as was done at the Baseline visit, however the subject will also be asked to complete a pain assessment. Both the surgeon and the subject will provide an assessment of his/her satisfaction with the hernia repair. The activities at Months 12 and 24 mirror those of Days 30 and 90, however the visit window is extended to +/- 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OviTex Permanent 1S | Other | All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OviTex 1S Permanent | Device | OviTex 1S Permanent is a reinforced tissue matrix consisting of layers of extra-cellular matrix derived from sheep stomachs. The layers are embroidered together with a monofilament polypropylene. One side of the mesh has blue polypropylene stitching, which provides a surface conducive to native tissue growth. The other side of the mesh is a smooth surface intended to minimize tissue attachment (adhesions). |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Occurrences or Wound-related Events | The primary endpoints were number of participants experiencing an SSO or wound related event at the hernia repair site and the number of participants experiencing other complications <90 days after index surgery. These included seromas, hematomas, wound dehiscence, skin necrosis, fistulae, and infections. Complications such as ileus and bowel obstruction were also recorded. | within the first three months of the ventral hernia repair |
| Measure | Description | Time Frame |
|---|---|---|
| Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | Secondary outcome measures include the number of participants experiencing a hernia recurrence, post-operative SSO, wound related event at the hernia repair site, and other complications occurring at time points > 90 days after index surgery. | Overall Cumulative SSOs and Complications (0 - 24 Months) |
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Inclusion Criteria:
Exclusion Criteria:
Intra-operative Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| George DeNoto, MD | Saint Francis Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic | La Jolla | California | 92037 | United States | ||
| Sarasota Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36389188 | Derived | DeNoto G 3rd, Ceppa EP, Pacella SJ, Sawyer M, Slayden G, Takata M, Tuma G, Yunis J. 24-Month results of the BRAVO study: A prospective, multi-center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex(R) 1S permanent reinforced tissue matrix. Ann Med Surg (Lond). 2022 Sep 27;83:104745. doi: 10.1016/j.amsu.2022.104745. eCollection 2022 Nov. | |
| 34768516 |
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Of 95 patients were consented, 3 did not meet eligibility criteria and were not enrolled. Only 92 patients were enrolled in the study and received OviTex 1S Permanent reinforced tissue matrix during their hernia repair procedure.
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| ID | Title | Description |
|---|---|---|
| FG000 | OviTex Permanent 1S | All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
95 subjects consented for participation in the study. 3 subjects did not meet all eligibility criteria and as such, 92 subjects were enrolled and underwent hernia repair procedures with OviTex 1S.
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| ID | Title | Description |
|---|---|---|
| BG000 | OviTex Permanent 1S | All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 | Surgical Site Occurrences or Wound-related Events | The primary endpoints were number of participants experiencing an SSO or wound related event at the hernia repair site and the number of participants experiencing other complications <90 days after index surgery. These included seromas, hematomas, wound dehiscence, skin necrosis, fistulae, and infections. Complications such as ileus and bowel obstruction were also recorded. | Posted | Count of Participants | Participants | within the first three months of the ventral hernia repair |
|
Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
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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 | OviTex 1S Permanent | All subjects included in this post-market study will have a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MEDDRA 20.0 English | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MEDDRA 20.0 English | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neal Overbeck | TELA Bio | 484-802-9570 | noverbeck@telabio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2017 | Jun 12, 2023 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point | Hernia-Related Quality-of-Life Survey (HerQLes) assesses abdominal wall function and impact of ventral hernia repair on quality of life through 12 questions. Responses are graded on a likert scale from 1 to 6, 1=strongly disagree, 2=moderately disagree, 3=slightly disagree, 4=slightly agree, 5=moderately agree, 6=strongly agree. A raw score is calculated by the following formula: 12 question average = (Response to Q1 + Response to Q2 +…+ Response to Q12) / 12 A summary score is calculated by the following formula: HerQLes Summary Score = 120-20*(12 Question Average) HerQLes scores range from 0 (worst possible response) to 100 (best possible response). Data is reported as change in HerQLes Summary Score from baseline to each time point The scale was first reported in Krpata, D. M. et al. Design and Initial Implementation of HerQLes: A Hernia-Related Quality-of-Life Survey to Assess Abdominal Wall Function. J Am Coll Surgeons 215, 635-642 (2012). | Baseline through 24 months |
| Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point | EuroQol 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) is a standardized generic (disease non-specific) quality of life scale measuring how good or bad the patients' health is on their visit date. The patient indicates on the scale from 0 (the worst health you can imagine) to 100 (the best health you can imagine) how their health is with an X and reports the number in a box. Data is reported as change in EQ-5D VAS score from baseline to each time point. | Baseline through 24 Months |
| Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point | EuroQol 5 Dimensions (EQ-5D) is a standardized generic (disease non-specific) quality of life instrument measuring mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are coded from 1 to 5 (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems). The levels reported for each dimension create a 5-digit number (i.e. 11111 or 12345) based on patient response. These 5-digit numbers are converted to an index score by special algorithm that is not publicly available. The index value represents the patient's health status, where higher numbers are associated with better outcomes. Data is reported as change in EQ-5D Index value from baseline to each time point. | Baseline through 24 Months |
| Sarasota |
| Florida |
| 34239 |
| United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| St. Luke's Hospital South | Overland Park | Kansas | 66213 | United States |
| Capital Health | Trenton | New Jersey | 08638 | United States |
| St. Francis Hosptial | Roslyn | New York | 11576 | United States |
| Comanche County Memorial Hospital | Lawton | Oklahoma | 73505 | United States |
| Derived |
| DeNoto G 3rd, Ceppa EP, Pacella SJ, Sawyer M, Slayden G, Takata M, Tuma G, Yunis J. A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex(R) 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis. J Clin Med. 2021 Oct 27;10(21):4998. doi: 10.3390/jcm10214998. |
| 1 exited due to recurrence and 2 exited due to mesh removal. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | (kg/m^2) |
|
| modified Ventral Hernia Working Group Grade | Modified Ventral Hernia Working Group Grade is used to predict surgical site occurrence (SSO) based on patient comorbidities. Grade I patients are considered to have a low risk of complications and have no history of wound infection. Grade 2 patients are considered a higher risk for developing an SSO and have one of the following comorbidities: diabetes, COPD, immunosuppression, active smoker, or obese. Grade 3 patients are at the highest risk for developing an SSO and are considered contaminated with a stoma present, violation of gastrointestinal tract, infected mesh, or septic dehiscence | Count of Participants | Participants |
|
| Surgical Site Wound Classification | Count of Participants | Participants |
|
| Operative Approach | Count of Participants | Participants |
|
| Plane of Placement | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | Secondary outcome measures include the number of participants experiencing a hernia recurrence, post-operative SSO, wound related event at the hernia repair site, and other complications occurring at time points > 90 days after index surgery. | Posted | Count of Participants | Participants | Overall Cumulative SSOs and Complications (0 - 24 Months) |
|
|
|
| Secondary | Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point | Hernia-Related Quality-of-Life Survey (HerQLes) assesses abdominal wall function and impact of ventral hernia repair on quality of life through 12 questions. Responses are graded on a likert scale from 1 to 6, 1=strongly disagree, 2=moderately disagree, 3=slightly disagree, 4=slightly agree, 5=moderately agree, 6=strongly agree. A raw score is calculated by the following formula: 12 question average = (Response to Q1 + Response to Q2 +…+ Response to Q12) / 12 A summary score is calculated by the following formula: HerQLes Summary Score = 120-20*(12 Question Average) HerQLes scores range from 0 (worst possible response) to 100 (best possible response). Data is reported as change in HerQLes Summary Score from baseline to each time point The scale was first reported in Krpata, D. M. et al. Design and Initial Implementation of HerQLes: A Hernia-Related Quality-of-Life Survey to Assess Abdominal Wall Function. J Am Coll Surgeons 215, 635-642 (2012). | The number of participants at each time point differs from the overall number of participants analyzed (92) as not all participants completed the required questionnaires at each time point and therefore, only the questionnaires that were available to be analyzed are included. | Posted | Mean | Standard Deviation | scores on a scale | Baseline through 24 months |
|
|
|
| Secondary | Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point | EuroQol 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) is a standardized generic (disease non-specific) quality of life scale measuring how good or bad the patients' health is on their visit date. The patient indicates on the scale from 0 (the worst health you can imagine) to 100 (the best health you can imagine) how their health is with an X and reports the number in a box. Data is reported as change in EQ-5D VAS score from baseline to each time point. | The number of participants at each time point differs from the overall number of participants analyzed (92) as not all participants completed the required questionnaires at each time point and therefore, only the questionnaires that were available to be analyzed are included. | Posted | Mean | Standard Deviation | scores on a scale | Baseline through 24 Months |
|
|
|
| Secondary | Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point | EuroQol 5 Dimensions (EQ-5D) is a standardized generic (disease non-specific) quality of life instrument measuring mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are coded from 1 to 5 (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems). The levels reported for each dimension create a 5-digit number (i.e. 11111 or 12345) based on patient response. These 5-digit numbers are converted to an index score by special algorithm that is not publicly available. The index value represents the patient's health status, where higher numbers are associated with better outcomes. Data is reported as change in EQ-5D Index value from baseline to each time point. | The number of participants at each time point differs from the overall number of participants analyzed (92) as not all participants completed the required questionnaires at each time point and therefore, only the questionnaires that were available to be analyzed are included. | Posted | Mean | Standard Deviation | scores on a scale | Baseline through 24 Months |
|
|
|
| 4 |
| 92 |
| 34 |
| 92 |
| 24 |
| 92 |
| Cardiac arrest | Cardiac disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Fistula of small intestine | Gastrointestinal disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Intestinal fistula | Gastrointestinal disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Cirrhosis alcoholic | Hepatobiliary disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MEDDRA 20.0 English | Systematic Assessment |
|
| Abdominal wall abscess | Infections and infestations | MEDDRA 20.0 English | Systematic Assessment |
|
| Incision site abscess | Infections and infestations | MEDDRA 20.0 English | Systematic Assessment |
|
| Pelvic abscess | Infections and infestations | MEDDRA 20.0 English | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MEDDRA 20.0 English | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MEDDRA 20.0 English | Systematic Assessment |
|
| Sepsis | Infections and infestations | MEDDRA 20.0 English | Systematic Assessment |
|
| Subdiaphragmatic abscess | Infections and infestations | MEDDRA 20.0 English | Systematic Assessment |
|
| Complications of transplanted liver | Injury, poisoning and procedural complications | MEDDRA 20.0 English | Systematic Assessment |
|
| Incarcerated incisional hernia | Injury, poisoning and procedural complications | MEDDRA 20.0 English | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MEDDRA 20.0 English | Systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MEDDRA 20.0 English | Systematic Assessment |
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| Postoperative ileus | Injury, poisoning and procedural complications | MEDDRA 20.0 English | Systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | MEDDRA 20.0 English | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MEDDRA 20.0 English | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MEDDRA 20.0 English | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Lung carcinoma cell type unspecified stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 20.0 English | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Uterovaginal prolapse | Reproductive system and breast disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MEDDRA 20.0 English | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 20.0 English | Systematic Assessment |
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| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA 20.0 English | Systematic Assessment |
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| Pyrexia | General disorders | MEDDRA 20.0 English | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MEDDRA 20.0 English | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Hematoma |
|
| Wound Dehiscence |
|
| Skin Necrosis |
|
| Fistulae |
|
| SSI |
|
| Bowel Obstruction |
|
| Ileus |
|
| Any other non-surgery or hernia-related complication |
|
| Mesh removal (full) |
|
| Mesh removal (partial) |
|
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| Month 12 |
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| Month 24 |
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| Month 12 |
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| Month 24 |
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| Month 12 |
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| Month 24 |
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