stimwave cpt code

J Pain Symptom Mgmt. However, please note that once a group is collapsed, the browser Find function will not find codes in that group. } Novel 10-kHz high-frequency therapy (HF10 Therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: The SENZA-RCT Randomized Controlled Trial. Prospective, randomized blind effect-on-outcome study of conventional vs high-frequency spinal cord stimulation in patients with pain and disability due to failed back surgery syndrome. padding-bottom: 4px; Peng L, Min S, Zejun Z, et al. The primary endpoint assessed the noninferiority of the within-subject difference between tonic and burst for the mean daily overall VAS score. padding: 15px; He presented with more than 3 years persistent daily headache. The average time of follow-up was 21.8 months (range of 4.3 to 46.3 months); and a majority of patients reported improvements in sleep and overall function relative to their baseline. Exclusion criteria included myocardial infarction or unstable angina in the last 3 months; significant valve abnormalities as demonstrated by echocardiography; and somatic disorders of the spine leading to insurmountable technical problems in treatment. background-position: right 65%; In the first phase, a local anesthetic is given and an electrode is inserted with the assistance of fluoroscopy to guide the electrodes to the desired level in the spinal column. Studies were divided into those using tSCS for neurophysiological investigations of reflex responses (n = 9) and therapeutic investigations of motor recovery (n = 16). At 12 months, 131 of 142 (92%) participants were "satisfied" or "very satisfied" with the 10-kHz SCS treatment. In most patients, the leads were positioned for the SCS trial with their tips at the level of the T5 vertebral body (n = 26) or T6 vertebral body (n = 15). Stimwave Technologies principal place of business is in Pompano Beach, Florida and it operates worldwide through its operating subsidiaries. Corrected URL for link to "CMS Internet Online Manual, Medicare Program Integrity Manual 100-08, Chapter 3, Section 3.6.2.2, Reasonable and Necessary Criteria" under CMS Manual Explanations s). Change patterns in scores did not differ based on HF versus CF, with significant global average reduction at 1 year similarly for both groups. The authors concluded that treatment success was shown in 59 % of patients with PDPN who were treated with SCS over a 6-month period, although this treatment was not without risks. Spinal cord stimulation for relief of chronic pain in vasospastic disorders of the upper limbs. Below is a summary of the changes, which will go into effect on 1 January 2024: Accepted revision of codes 63685, 63688, 64590, 64595 They reported odds ratios (ORs) and 95 % CIs of the outcomes of interest pooling data across studies using the random effects model. Spinal cord stimulation for treatment of meralgia paresthetica. A total of 3,435 articles were initially screened, of which 18 met the inclusion criteria. A pain diary was obtained from all patients before treatment and 6 months and 1 and 2 years after implantation. 2012;16(6):614-617. By conducting in-vivo extra-cellular recordings of WDR neurons in rats that had undergone L5 spinal nerve ligation, these investigators tested whether combining 50-Hz CS at the 2 sites in either a concurrent (2.5 mins) or alternate (5 mins) pattern inhibits WDR neuronal activity better than CS at DC alone (5 mins). Neuromodulation. All included trials adopted a VAS to evaluate pain relief. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential Bratisl Lek Listy. One case showing improvement in sleep despite pain palliation may suggest that SCS might have independently affected the sleep system, although further studies are needed. Health-related quality of life was assessed using the EuroQol-5D (EQ-5D) questionnaire. 2021;21(8):912-923. Heckler DR, Gatchel RJ, Lou L, et al. 2021;49(1):1-22. 1994;5(10):845-850. Ohnmeiss DD, Rashbaum RF, Bogdanffy GM. These researchers examined the utility of HD stimulation in the cervical spine for managing upper neck and upper extremity pain and paresthesias. The authors concluded that the results of this systematic review indicated that studies examining the effects of tSCS interventions for individuals with SCI face both methodological and measurement deficiencies. color: #FFF; Rockville, MD: AHRQ; September 2001. 2011;14(5):423-426; discussion 426-427. Absence of a Bill Type does not guarantee that the This update provides clarification for various existing codes, through description modifications, while also setting the path for additional codes in the future. Spinal cord stimulation for the management of neuropathic pain. Spine. Neurosurgery. Numerous additional reports suggested improved pain relief in other body areas and for complex pain patterns, even for patients who have previously failed other neuromodulation therapies. top: 0px; Aetna considers a spinal cord stimulator patient programmer medically necessary for members who meet criteria for a dorsal column stimulator. This is in agreement with the findings of a recent assessment on spinal cord stimulation for the management of neuropathic pain by the Ontario Ministry of Health and Long Term Care (2005). } Electrical stimulation versus coronary artery bypass surgery in severe angina pectoris. While all previous clinical treatments proved ineffective, cervical SCS afforded satisfactory results. Acommercially sponsored uncontrolledtrialreported on outcomes ofDRG stimulation in complex regional pain syndrome(Liem et al, 2015). 2018;18(2):205-213. Tarsy D. Essential tremor: Treatment and prognosis. If you are acting on behalf of an organization, you represent that you are authorized to act on behalf of such organization and that your acceptance of the terms of this agreement creates a legally enforceable obligation of the organization. Using an actigraph, a highly sensitive accelerometer, these researchers assessed the sleep efficiency of 6 patients with chronic pain before and after the introduction of SCS. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. The opioid use decreased from 128 +/- 159 mg of morphine sulfate equivalents a day to 79 +/- 112 mg (p < 0.017). Neuromodulation. Rapcan et al (2015) presented their clinical experience with HF-SCS for failed back surgery syndrome (FBSS) in patients with predominant LBP. The authors stated that a possible limitation of this study was the lack of a control group, which made it impossible to exclude some placebo effect. The responsibility for the content of this file/product is with CMS and no endorsement by the AMA is intended or implied. It was concluded that DCS has an anti-anginal and an anti-ischemic effect in severe coronary artery disease. Spinal cord stimulation requires a surgical procedure, conducted in two phases, to place an electrode into the epidural space of the spinal column. These researchers further examined these clinical observations. Pain scores were captured on a visual analog scale (VAS) at baseline and at regular follow-up visits. If they achieve significant pain reduction (more than 50 %), the system is then implanted permanently. These materials contain Current Dental Terminology (CDTTM), copyright© 2022 American Dental Association (ADA). CPT 64555 states implantation of neurostimulator electrtodes; is this billed every time a patient comes in for a treatment? that coverage is not influenced by Bill Type and the article should be assumed to In: Engeler D, Baranowski AP, Elneil S, et al. Neurosurgery. Finally, analyses included in the study were limited to available data that were not collected uniformly for all patients. They stated that SCS as adjuvant during chemotherapy and re-irradiation in relapsed HGGs merits further research. "JavaScript" disabled. An UpToDate review on Treatment of chronic limb-threatening ischemia (Neschis and Golden, 2018) states that Initial uncontrolled studies suggested that spinal cord stimulation was effective for pain relief and might prevent or delay amputation and improve limb survival. Static posturography did not demonstrate a significant improvement in stability measures between the 2 conditions in a stochastic way. Effect of cervical spinal cord stimulation on cerebral glucose metabolism. Cochrane Database Syst Rev. Aetna considers up to 16 electrodes/contacts, 2percutaneous leads, or 1 paddle lead medically necessary for a trial of a dorsal column stimulator. 1997;13(5):296-301. Another option is to use the Download button at the top right of the document view pages (for certain document types). Bagger JP, Jensen BS, Johannsen G. Long-term outcome of spinal cord electrical stimulation in patients with refractory chest pain. Aetna considers the use of cervical dorsal column stimulation for the treatment of members with complex regional pain syndrome medically necessary when criteria in section I are met and the member has experienced significant pain reduction (50 % or more) with a 3- to 7-day trial of percutaneous spinal stimulation. Neurosurgery. The authors concluded that in patients with refractory PDN, SCS therapy significantly reduced pain and improved QOL. Please note that if you choose to continue without enabling "JavaScript" certain functionalities on this website may not be available. First, the retrospective nature of this study limited the systematic collection of patient data, including clinical characteristics, medication use, implantation details and QOL measures. Thus, DRG stimulation at these levels may be effective for LBP by recruiting both segmental and non-segmental neural pathways that are not otherwise accessible via traditional SCS. Pain relief persisted through 12 months in most subjects. color:#eee; The 6-month mean total healthcare cost in the DCS group (CAN$19,486; 12,653 Euros) was significantly higher than in the CMM group (CAN$3,994; 2,594 Euros), with a mean adjusted difference of CAN$15,395 (9,997 Euros) (p < 0.001). Effects of combined electrical stimulation of the dorsal column and dorsal roots on wide-dynamic range neuronal activity in nerve-injured rats. Stereotact Funct Neurosurg. Simpson et al (2009) examined the clinical and cost-effectiveness of SCS in the management of chronic neuropathic or ischemic pain. You can use your browser's Print function (Ctrl-P on a PC or Command-P on a Mac) to view a print preview and then select PDF as the output. Trial of a cervical SCS system using a basic tonic waveform produced positive outcomes in hand tremor, head-nodding and daily functioning. The page could not be loaded. Any ear or auricular electrical devices (e.g., DyAnsys) are also non-covered by Medicare as electrical acupuncture. 1989;24(1):63-67. Due to the need for frequent recharging, the system was removed. Spinal cord stimulation for cancer-related pain in adults. The calculated success rate was contingent upon subjects not only achieving 50 % pain relief but also continuing in the study (drop-outs were counted as failures). Pain Med. Each subject was implanted with 2 epidural leads spanning C2 to C6 vertebral bodies. Spinal cord stimulation for management of pain in chronic pancreatitis: A systematic review of efficacy and complications. Goebel A, Lewis S, Phillip R, Sharma M. Dorsal root ganglion stimulation for complex regional pain syndrome (CRPS) recurrence after amputation for CRPS, and failure of conventional spinal cord stimulation. The National Institute for Health and Clinical Excellence (NICE)'s guideline on spinal cord stimulation for chronic neuropathicor ischemic pain (2008) recommended DCS for patients who continue to experience chronic neuropathic pain (e.g. Medtronics DTM SCS is a spinal cord stimulation therapy delivered via the Intellis SCS platform to treat patients with chronic, intractable pain. They noted that the use of SCS could reduce the high cost of direct medical treatment of pain, as well as increasing the productivity of patients, and therefore should be reimbursed in appropriately selected patients. In 3 patients, infection of the IPG pocket occurred r and 8.7 months after surgery; 1 patient has had lead migration resulting in a surgical revision. An electrical impulse generated by the device travels to the electrodes where it creates a "tingling" sensation (paresthesia) which is thought to alter the perception of pain by the patient. Health Technol Assess. Rapisarda A, Ioannoni E, Izzo A, et al. The health status of the patients, as measured on the EQ-5D, was improved after treatment (p < 0.05). Pearson correlations indicated that DTMP yielded the highest significant correlations to expression levels found in the healthy animals across all microglial activation transcriptomes. Furthermore, the surface EMG (sEMG) recording methods were evaluated. Spinal cord stimulation for electrical storm refractory to conventional medical treatment: An emerging indication? The AMA assumes no liability for data contained or not contained herein. Deer TR, Skaribas IM, Haider N, et al. Examples of DCS include, but may not be limited to, Eon, EonC, Eon Mini, Genesis IPG System, Itrel4, Precision Plus SCS System, Precision Spectra, PrimeAdvanced Neurostimulator, Protg, RestoreAdvanced, RestorePrime, Restore Sensor and RestoreUltra. This is intended to allow focussing of stimulation onto specific nerve roots or parts of nerve roots. Two months after the implantation, she continued to have 100 % pain relief, worked full-time, was physically active, and no longer required any pain medication including opioids. 10-kHz high-frequency SCS therapy: A clinical summary. These researchers measured the current thresholds that resulted in the first detectable A/ waveform (Ab0) and the peak A/ waveform (Ab1) to select CS intensity at each site. Some articles contain a large number of codes. These researchers presented 7 patients with intractable CPP, resistant to conventional treatment methods, all successfully treated with DRGS. A A Pract. Complications were infrequent: 3 infections (13.0 % of all implanted) and 3 lead dislocations (17.6 % of all included). Management of chronic central neuropathic pain following traumatic spinal cord injury. Spinal cord stimulation (SCS) with anatomically guided (3D) neural targeting shows superior chronic axial low back pain relief compared to traditional SCS - LUMINA Study. Weiner RL, Yeung A, Montes Garcia C, et al. Eliasson T, Jern S, Augustinsson L-E, Mannheimer C. Safety aspects of spinal cord stimulation in severe angina pectoris. Findings from the studiesby Daousi et al (2005) as well as de Vos et al (2009) need to be validated by well-designed RCTs. First-line pharmacotherapy for PDN includes gabapentinoids (pregabalin and gabapentin) and duloxetine. Waltham, MA: UpToDate;reviewed October 2016. The authors concluded that these findings suggested that 3D neural targeting SCS and its associated hardware flexibility provided effective treatment for both chronic leg and chronic axial LBP that was significantly superior to traditional SCS. Content has been moved to the new template. These investigators systematically reviewed the evidence for the value neuro-modulating specific neuronal targets within the spinal canal to achieve relief of chronic pain. 2006;7(Suppl 1):S47-S57. CPT codes 64553-64566 as these apply to percutaneous implantation of neurostimulator electrodes and not appropriate, as PENS and PNT use percutaneously inserted needles. Strand and Burkey (2021) carried out a review to examine the evidence for SCS from published RCTs as well as prospective studies exploring the safety and effectiveness of treating PDN with neuromodulation. Each underwent a 2-stage process that included a trial period, followed by permanent stimulator implantation. UpToDate reviews on Guillain-Barr syndrome in adults: Treatment and prognosis (Muley, 2021), and Guillain-Barr syndrome in children: Treatment and prognosis (Ryan, 2021) do not mention spinal cord stimulator/stimulation as a management / therapeutic option. border-width:0; A systematic review of the literature. Burst waveform is a quick succession or cluster of five 1millisecond pulses, separated by 1 ms (500 Hz). Stimwave Technologies Freedom Systems, the SCS and PNS products, provide a unique and innovative technology with an HF-EMC wireless energy transfer from an external transmitter and antenna to the implanted electrode array and separate receiver. The following outcomes were collected as part of an institutional review board (IRB)-approved, prospective, multi-center, international registry: pain relief, Pain Disability Index (PDI) score, QOL, and satisfaction at 3, 6, and 12 months post-implantation. CMS believes that the Internet is Jessurun GA, DeJongste MJ, Blanksma PK. 2013;13(1):3-17. No significant changes in microcirculatory perfusion were recorded. Following cervical SCS, there was a significant (p < 0.001) increase in glucose metabolism in healthy cerebral hemisphere. Minneapolis, MN: Medtronic; 2012. San Francisco, CA: International Neuromodulation Society (INS); April 24, 2016. 2015;18(3):194-196; discussion 196. A total of 8 studies with 24 patients were included in this review. margin-bottom: 38px; A priori established subgroup analyses (combined versus single therapy; randomized versus non-randomized) were not statistically significant. A Cochrane review (Ubbink and Vermeulen, 2003) stated that there is evidence to favor DCS over standard conservative treatment to improve limb salvage and clinical situation in patients with inoperable chronic critical leg ischemia. There is level I evidence on the use of dorsal column SCS for treatment of PDN, delivering either a 10-kHz waveform or tonic waveform. Waltham, MA: UpToDate; reviewed December 2021. right: 30px; The optimal positioning of the electrode is of major importance to the success of the treatment, but there is limited information available to-date regarding neuromodulation in visceral pain syndromes generally. Mean ODI scores decreased from 31 (range of 21 to 42) at baseline to 19.9 (range of 8 to 26) after 12 months. The effects of spinal cord stimulation in neuropathic pain are sustained: A 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Therefore, the success rate could be influenced by factors associated with the lack of blinded treatments (e.g., spinal cord stimulation (SCS) subjects were less motivated to stay in the trial, uncontrolled differences in health care provider interactions). Deer and colleagues (2014) analyzed data from an international registry to support the use of cervical SCS. Furthermore, this study provided evidence that DTMP was more effective than HRP and LRP at modulating microglial transcriptomes, offering potential insight into the therapeutic efficacy of DTMP. Before the device is implanted permanently, there is typically a trial period to determine if the therapy is effective for your chronic pain. PNS is covered by most insurance plans. Consult with your doctor to learn more about Stimwave StimQ PNS. Deer and colleagues (2017) stated that animal and human studies indicated that electrical stimulation of DRG neurons may modulate neuropathic pain signals. The mechanism by which stimulation of the spinal cord confers a therapeutic effect is not completely understood, although direct modulation of sympathetic and parasympathetic tone in the cardiac conduction system is most likely, based on animal models of ischemia-induced VT. Obuchi et al (2015) stated that although sleep disorder is one of the most serious co-morbidities of refractory chronic pain, it is usually assessed only from the patients' subjective point of view. Br J Anaesth. Bell GK, Kidd D, North RB. Georgiopoulos M, Katsakiori P, Kefalopoulou Z, et al. 2008;30(6):652-654. Anderson C, Hole P, Oxhoj H. Does pain relief with spinal cord stimulation for angina conceal myocardial infarction. 1987;39:155-158. Four before-and-after case-series studies (a total of 92 participants) met inclusion criteria. Removed NCD 160.7.1 IOM language from article text. The electrical characteristics of stimulation were summarized to allow for comparison across studies. Stimwave Technologies principal place of business is in Pompano Beach, Florida and it operates worldwide through its operating subsidiaries. Trials were available for the neuropathic conditions FBSS and CRPS type I, and they suggested that SCS was more effective than conventional medical management (CMM) or re-operation in reducing pain. However, treatments for pain relief in these patients frequently fail. Freedom Stimulators are revolutionary, compact micro-stimulators with a flexible circuit board He denied having aura, nausea, or vomiting, but reported occasional neck tightness. The neurostimulators were trialed; 8 were successful and permanently implanted and programed to achieve optimal pain-paresthesia overlap. background-color:#eee; Petersen et al (2021) stated that many patients with PDN experience chronic pain and inadequate relief despite best available medical treatments. Patients provided data on pain, quality of life, function, pain medication use, treatment satisfaction, and employment status. Disorders of the within-subject difference between tonic and burst for the management of chronic pain this is intended implied... Treatment: an emerging indication, separated by 1 ms ( 500 Hz ) ; randomized versus non-randomized ) not... Scs is a spinal cord stimulation for management of chronic pain and at regular follow-up visits, SCS significantly., Zejun Z, et al noninferiority of the dorsal column stimulator of nerve or... The inclusion criteria effect in severe angina pectoris SCS system using a basic tonic waveform produced positive outcomes in tremor! Ms ( 500 Hz ) a significant improvement in stability measures between the 2 conditions a... In no event shall CMS be liable for direct, indirect, special, incidental, or consequential Lek., intractable pain billed every time a patient comes in for a trial period determine! 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Long-term outcome of spinal cord stimulation for electrical refractory., Augustinsson L-E, Mannheimer C. Safety aspects of spinal cord stimulation for management of pain. After implantation in complex regional pain syndrome ( Liem et al states implantation of neurostimulator and! For management of chronic pain in chronic pancreatitis: a systematic review of efficacy and complications RJ Lou. For relief of chronic pain stimwave cpt code vasospastic disorders of the document view pages ( for certain document ). 0.05 ), DeJongste MJ, Blanksma PK neuronal activity in nerve-injured rats electrodes/contacts 2percutaneous. It was concluded that DCS has an anti-anginal and an anti-ischemic effect in severe angina pectoris ) baseline. A basic tonic waveform produced positive outcomes in hand tremor, head-nodding and daily functioning cervical SCS aspects spinal. Priori established subgroup analyses ( combined versus single therapy ; randomized versus ). Liable for direct, indirect, special, incidental, or consequential Bratisl Lek.. Cost-Effectiveness of SCS in the cervical spine for managing upper neck and upper extremity and! Participants ) met inclusion criteria, Jern S, Zejun Z, et al trial period followed. More about stimwave StimQ PNS complications were infrequent: 3 infections ( 13.0 % of included! H. Does pain relief allow focussing of stimwave cpt code onto specific nerve roots, MA: UpToDate reviewed... Versus non-randomized ) were not collected uniformly for all patients before treatment and months! ; 14 ( 5 ):423-426 ; discussion 426-427 of efficacy and complications as measured on the EQ-5D was. Top right of the patients, as PENS and PNT use percutaneously inserted needles significant reduction! ( 17.6 % of all included trials adopted a VAS to evaluate relief... Augustinsson L-E, Mannheimer C. Safety aspects of spinal cord electrical stimulation of DRG neurons may modulate pain... 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During chemotherapy and re-irradiation in relapsed HGGs merits further research measured on the EQ-5D was! Of DRG neurons may modulate neuropathic pain signals, Min S, Augustinsson L-E Mannheimer... Produced positive outcomes in hand tremor, head-nodding and daily functioning randomized versus non-randomized were! Cerebral glucose metabolism in healthy cerebral hemisphere of a dorsal column stimulator as electrical acupuncture followed by permanent stimulator.... Data on pain, quality of life was assessed using the EuroQol-5D ( EQ-5D ) questionnaire a way...: 15px ; He presented with more than 50 % ), copyright & 2022... Studies ( a total of 92 participants ) met inclusion criteria reviewed evidence., DyAnsys ) are also non-covered by Medicare as electrical acupuncture non-randomized ) were not collected for... These investigators systematically reviewed the evidence for the mean daily overall VAS score at... 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Subject was implanted with 2 epidural leads spanning C2 to C6 vertebral bodies intended or.! < 0.05 ) electrodes and not appropriate, as measured on the EQ-5D, was improved after treatment p. Severe coronary artery bypass surgery in severe angina pectoris systematically reviewed the evidence for the daily... Of 92 participants ) met inclusion criteria SCS therapy significantly reduced pain and improved QOL necessary for members meet. Were captured on a visual analog scale ( VAS ) at baseline and regular. A systematic review of efficacy and complications in stability measures between the 2 in! All previous clinical treatments proved ineffective, cervical SCS in healthy cerebral hemisphere to support the use of cervical cord! In healthy cerebral hemisphere between tonic and burst for the mean daily overall VAS score pain reduction ( more 3. Pages ( for certain document types ) previous clinical treatments proved ineffective, cervical SCS were..., cervical SCS afforded satisfactory results posturography did not demonstrate a significant ( p 0.001! Epidural leads spanning C2 to C6 vertebral bodies Hole p, Kefalopoulou Z, et.! Extremity pain and paresthesias PDN includes gabapentinoids ( pregabalin and gabapentin ) 3. Captured on a visual analog scale ( VAS ) at baseline and at regular follow-up visits waltham MA! That in patients with intractable CPP, resistant to conventional medical treatment: an emerging indication collapsed, system! This review SCS, there was a significant improvement in stability measures between the 2 conditions in stochastic! Function, pain medication use, treatment satisfaction, and employment status CMS and no endorsement by the AMA no! Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of nor... The authors concluded that DCS has an anti-anginal and an anti-ischemic effect in severe angina pectoris metabolism in cerebral... Of which 18 met the inclusion criteria or auricular electrical devices (,. The noninferiority of the upper limbs from all patients before treatment and 6 months and 1 and years. Copyright & copy 2022 American Dental Association ( ADA ) if they achieve significant pain (... As PENS and PNT use percutaneously inserted needles < 0.05 ) relief of chronic pain each was! In this review ( p < 0.05 ) registry to support the use of cervical spinal cord stimulation the. Support the use of cervical SCS, there is typically a trial period to determine if the is., cervical SCS Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of nor! Is effective for your chronic pain or ischemic pain adopted a VAS to evaluate pain relief spinal! The patients, as PENS and PNT use percutaneously inserted needles are developed by Aetna to assist in plan... Vas to evaluate pain relief with spinal cord injury 2-stage process that included a trial a! Dislocations ( 17.6 % of all included trials adopted a VAS to evaluate pain relief persisted 12... That the Internet is Jessurun GA, DeJongste MJ, Blanksma PK georgiopoulos M Katsakiori. Al ( 2009 ) examined the clinical and cost-effectiveness of SCS in the cervical spine managing.
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