Symptom management of multiple sclerosis in adults. A pain diary was obtained from all patients before treatment and 6 months and 1 and 2 years after implantation. These researchers presented the case of an MS patient (13-year history) with late-stage disease. The StimRouter Reimbursement Group is committed to collaborating with healthcare professionals and patients to navigate through the reimbursement process. Performing this procedure results in a net loss; the cost of the implant is $10,000 more than the total reimbursement 2010;88(4):199-207. PNS involves a tiny implanta wire about the thickness of a human hair or a group of electrodes about the size of a standard paperclipthat delivers electrical impulses, similar to a pacemaker, to the nerve. Call Today for Pain Relief Tomorrow: 800.965.5134 Are You Ready for Less Pain and More Living? They stated that SCS as adjuvant during chemotherapy and re-irradiation in relapsed HGGs merits further research. Intra-spinal stimulation of non-dorsal column targets may well be the future of neuro-stimulation as it provides new clinically significant neuro-modulation of specific therapeutic targets that are not well or not easily addressed with conventional dorsal column SCS. Across eight patients, the average baseline pain rating was 85.5mm. Huygen et al (2018) noted that chronic low back pain (LBP) affects millions of people worldwide and can arise through a variety of clinical origins. The primary endpoint evaluated in the intention-to-treat (ITT) population was met by 5 of 94 patients in the CMM group (5 %) and 75 of 95 patients in the 10-kHz SCS plus CMM group (79 %; difference, 73.6 %; 95 % CI: 64.2 to 83.0; p < 0.001). Member experienced significant pain reduction (50 % or more) with a 3- to 7-day trial of percutaneous spinal stimulation. 1997;13(5):296-301. These reductions in pain were associated with improvements in QOL. Stimwave Technologies Inc. 1310 Park Central Boulevard South Pompano Beach, Florida 33064 Re: K182720 Trade/Device Name: Freedom Spinal Cord Stimulator (SCS) System Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZB Dated: February 28, 2019 The authors found that DCS significantly improved quality of life and exercise capacity in these patients and that the beneficial effects of DCS may be mediated via an improvement of oxygen supply to the heart in addition to an analgesic effect. There was a special subgroup of 5 patients with regular change of frequencies between high frequency and conventional frequency (with paresthesia) also with significant leg and LBP relief. Smith et al (2021) noted that while numerous studies and patient experiences have demonstrated the efficacy of SCS as a treatment for chronic neuropathic pain, the exact mechanism underlying this therapy is still uncertain. Nuvectra MedicalsAlgovita spinal cord stimulatorhas the capability for up to three leads with a lead portfolio of both 8 and 12 contact leads. Medical notes documenting the following, when applicable: Indicate if this request is for a trial or permanent placement; if for permanent placement, include: 02:32 PM. The authors concluded that despite there being enough evidence to consider upper cervical spinal cord stimulation as an effective treatment for patients with neuropathic trigeminal pain, a RCT is needed to fully evaluate its indications and outcomes and compare it with other therapeutic approaches. #1 My pain management provider coded this procedure with 64555-51 (2 units), 64575, 64590 (2 units). padding: 15px; Pain Pract. Note: Achange in battery for spinal cord stimulator because of parasthesias is considered not medically necessary. An intention-to-treat analysis was conducted using data at the 12- and 24-week visits. Martelletti P, van Suijlekom H. Cervicogenic headache: Practical approaches to therapy. Neurodegenerative cerebellar ataxias are considerably uncommon, and this group of patients was relatively small (n = 20) and heterogeneous, so clear-cut associations need to be made with caution. L8688 . An extensive work-up was carried out under the direction of the patient's primary neurologist. Subjects had symptoms for at least 12 months that were refractory to medications, lower limb pain of greater than or equal to 5 on the 10-cm VAS, HbA1c of less than or equal to 10 %, and BMI of less than or equal to 45 kg/m2. Visual analog scale (VAS) were measured with the stimulator off and on, respectively: background pain [74.5 (63 to 79) mm versus 25 (17 to 33) mm, median (inter-quartile range),p = 0.03), peak pain (85 (80 to 92) mm versus 19 (11 to 47) mm,p = 0.03]. Slangen R, Schaper NC, Faber CG, et al. Grabow TS, Tella PK, Raja SN. Tripolar spinal cord stimulation for the treatment of abdominal pain associated with irritable bowel syndrome. Amirdelfan K, Vallejo R, Benyamin R, et al. Outcomes were recorded at follow-ups (1, 3, 6, 12, 23 months post-implant) and included patient self-reported changes, clinical observations, hand-writing assessments and The Essential Tremor Rating Assessment Scale scores. A prospective study of dorsal root ganglion stimulation for the relief of chronic pain. Complications were infrequent: 3 infections (13.0 % of all implanted) and 3 lead dislocations (17.6 % of all included). Electrical storm ceased thereafter, though ventricular function from progressive cardiomyopathy worsened, requiring heart transplantation several months later. The authors stated that electrical stimulation (high cervical spinal cord stimulation [SCS]) produced complete relief from the painful paroxysms. The ESBY study. Clinical studies have also concluded that HF10 SCS did not generate paresthesia nor was it necessary to provide adequate coverage for pain relief. The approval included indications for use: the device is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as The authors stated that this study had several drawbacks. J Diabetes Sci Technol. PLoS One. Sidiropoulos C, Masani K, Mestre T, et al. Stimwavespinal cord stimulator has the ability for physicians to utilizea configuration of up to 64 contacts. 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. 2009;13(17):iii, ix-x, 1-154. Studies on repetition rate, session duration, and number of sessions have not been performed for cerebellar tDCS,41 and the optimal repetition rate and inter-stimulus interval still have to be determined. 1993;307(6902):477-480. For more information, please visit https://stimwavefreedom.com/. Treatment of chronic limb-threatening ischemia. According to the 16 eligible studies, medical management by dopaminergic agents (levodopa, amantadine), zolpidem and median nerve stimulation, or surgical management by deep brain stimulation, extra-dural cortical stimulation,SCS and intra-thecal baclofen have shown to improve the level of consciousness in certain cases. A 74-year old man presented at the authors clinic with severe intractable pain, dysesthesia, and allodynia of the left foot caused by idiopathic small fiber neuropathy, confirmed by skin biopsy. In a prospective, open-label study, de Vos et al (2009) evaluated the safety and effectivenessof SCS for the treatment of pain and the effects on microcirculatory blood flow in the affected areas in patients with refractory peripheral diabetic neuropathy. Spatiotemporal gait assessment using an electronic walkway and static posturography were obtained and analyzed in a blinded manner with and without stimulation. Shatin D, Mullett K, Hults G. Totally implantable spinal cord stimulation for chronic pain: Design and efficacy. Waltham, MA: UpToDate; reviewed November 2019. Some patients reduced or eliminated pain medications. position: fixed; A total of 24 patients with back pain greater than leg pain who were candidates for spinal cord stimulation (SCS) were trialed at 5 U.S. centers. El Majdoub et al (2019) noted that SCS overlaps painful areas with paresthesia to alleviate pain; 10-kHz HF SCS (HF10 cSCS) constitutes a therapeutic option that could provide pain relief without inducing paresthesia. Rockville, MD: AHRQ; March 1994. New. CPT/HCPCS Codes* Required Clinical Information . Simpson EL, Duenas A, Holmes MW, et al. Neuromodulation. Temporary trial SCS evaluated eligibility for permanent device implant with success defined as greater than or equal to 50 % pain relief. Medtronics DTM SCS is a spinal cord stimulation therapy delivered via the Intellis SCS platform to treat patients with chronic, intractable pain. While the authors believed that this generalizability is critical to the objective of the study, it did inherently result in patient heterogeneity. Spinal cord stimulation for cancer-related pain in adults. 2022;45(1):e3-e6. Pain treatment depends principally on the underlying etiology with concurrent administration of anti-depressants, anti-convulsants, opioids, and topical treatments like capsaicin and local anesthetics. The investigators reported that treatment with 10-kHz SCS improved HRQoL, including a mean improvement in the EuroQol 5-dimensional questionnaire index score of 0.136 (95% CI, 0.104-0.169). 2008;12(8):1047-1058. Pain localized to the back, legs, and feet was reduced by 42 %, 62 %, and 80 %, respectively. Health Technology Literature Review. It is a proprietary therapy supported by pre-clinical research and clinical research with level 1 evidence at 12-month follow-up from a RCT (Fishman et al, 2020), which was presented at a Medtronic webinar; it has not gone through the peer-reviewed process. 2021;21(8):912-923. Pain Pract. These investigators found no evidence that DCS concealed acute myocardial infarction. } Minimally invasive Small device implanted under the skin. Deer TR, Levy RM, Kramer J, et al. Chang et al (2017) stated that conventional dorsal column SCS provides less than optimal pain relief for certain pain syndromes and anatomic pain distributions. Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. Turner et al (2004) conducted a systematic review on the effectiveness of DCS in relieving pain and improving functioning for patients with FBSS and CRPS. Reimbursement for permanent implantation of the system is reduced from an average of $22, 000 to $7, 200 3. The authors concluded that with continued programming, the patient reported further improvements to tremor and functionality, with minimal tremor remaining at 12 to 23 months; no major AEs were reported. In a RCT with a 1-year follow-up (n = 22), de Jongste and Staal (1993) found that DCS improved both the quality of life and cardiac parameters of patients with refractory angina pectoris. Yang F, Zhang T, Tiwari V, et al. Hope and Gruber (2012) noted that only 1 case report was found that discussed SCS for treatment of coccygodynia after a coccygeal fracture . The beneficial effect of spinal cord stimulation in a patient with severe cerebral ischemia and upper extremity ischemic pain. This was a single-case study; these preliminary findings need to be validated by well-designed studies. All included trials adopted a VAS to evaluate pain relief. Taylor RS, Van Buyten J-P, Buchser E. Spinal cord stimulation for chronic back and leg pain and failed back surgery syndrome: A systematic review and analysis of prognostic factors. After a trial period of percutaneous stimulation,8 male patients had been implanted with a permanent system. right: 30px; Rapcan et al (2015) presented their clinical experience with HF-SCS for failed back surgery syndrome (FBSS) in patients with predominant LBP. Additional pharmacologic modalities that are approved by the FDA but are considered 2nd-line agents include tapentadol and 8 % capsaicin patch, although studies have revealed modest treatment effects from these modalities. There is evidence that outcomes of DCS are improved if candidates are subject to psychological clearance to exclude from surgery persons with serious mental disabilities, psychiatric disturbances, or poor personality factors that are associated with poor outcomes. 2013;2:CD009389. Case reports -- limited essentially to the percutaneous insertion of spinal cord electrodes for dorsal column stimulation -- tend to focus on details of the method, to use non-uniform patient selection criteria, and to use heterogeneous pain assessment methods and follow-up duration. 1988;51(6):333-337. Measures included pain VAS, neurological examination, health-related quality of life (EuroQol Five-Dimension questionnaire), and HbA1c over 6 months. A total of 36 patients with a definitive implant were included in this study. A total of 100 patients were randomized to either the DCS or CMM group. As the pain was not satisfactorily controlled by conventional therapy, DRG stimulation was proposed to the patient and, after informed consent, a specifically designed percutaneous stimulation lead was placed over the left L5 DRG and connected to an external neuro-stimulator. They compared CMM with 10-kHz SCS plus CMM. The authors concluded that DTM SCS has the potential to improve outcomes for patients with chronic back pain. Neuromodulation. One patient had a second electrode implanted in the cervical region which relieved typical neuropathic hand pains. 2013;16(1):67-71; discussion 71-72. In a case report, Rana and Knezevic (2013) described the use of transverse tripolar DCS in a patient with a history of irritable bowel syndrome (IBS) associated with abdominal pain resistant to conservative treatments. The mean neck and upper limb pain at baseline was 8.8 (range of 7.0 to 10) and 7.5 (range of 6.0 to 9.0) according to the VAS. 9. 2012;17(3):150-158. Finally, the effect of tDCS on cognitive functions was not objectively assessed in this study. During permanent implantation most of the physicians used 2 octrode leads and were positioned mid-line at T5 to T6 levels. The authors concluded that from this clinical case, SCS is an effective and alternative treatment option for SOD. Additional case reports have been published on DRG in upper extremity complex regional pain syndrome (Garg and Danesh, 2015), and in complex regional pain syndrome of the knee (van Bussel, et al, 2015). He presented with more than 3 years persistent daily headache. Spinal cord stimulation for management of pain in chronic pancreatitis: A systematic review of efficacy and complications. These researchers found a total of 13 articles that satisfied the search criteria on targeted, non-dorsal column intra-spinal stimulation for pain. Neuromodulation. 2005;8(3):315-318. 1991a;28(5):685-690, discussion 690-691. A total of 3,435 articles were initially screened, of which 18 met the inclusion criteria. At the lower intensity (Ab0), no CS inhibited WDR neurons. z-index: 99; History, physical examination, and diagnostic work-up were consistent with meralgia paresthetica. UpToDate [serial online]. The assessment states: "Percutaneous electrical stimulation for the relief of otherwise refractory cancer pain has likewise not yet been evaluated in controlled trials. The published therapeutic responses must be substantiated by further clinical studies of sound methodology. Eighty percent of subjects receiving a permanent implant had a diagnosis of failed back surgery syndrome. Waltham, MA: UpToDate;reviewed October 2016. In contrast, HRP or LRP yielded weak or very weak correlations for these transcriptomes. Surg Neurol Int. Neuromodulation. HF10 SCS uses a charge-balanced stimulation waveform that has been shown to be safe in both animal and human studies. Quality of life, resource consumption and costs of spinal cord stimulation versus conventional medical management in neuropathic pain patients with failed back surgery syndrome (PROCESS trial). 2005;36(3):357-362. For more information, please visit. 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. In a systematic review, these researchers examined the methodology of studies using tSCS to generate motor activity in persons with SCI and assessed the quality of included trials. The estimated median age of the study group was 44years (range of 21 to 87) in primarily non-alcoholic CP (74 %, 23/31). These findings need to be validated by well-designed studies. Pain relief exceeded 50 % in 66 of 70 patients reported. 2009;23(1):40-45. Given that DRG-SCS and t-SCS target different spinal pathways, a failure with t-SCS should not automatically preclude a patient from attempting DRG-SCS. Effects of spinal cord stimulation in angina pectoris induced by pacing and possible mechanisms of action. Royal College of Obstetricians and Gynaecologists (RCOG). Clinical and cost-effectiveness analysis of an open label, single-centre, randomised trial of spinal cord stimulation (SCS) versus percutaneous myocardial laser revascularisation (PMR) in patients with refractory angina pectoris: The SPiRiT trial. Spinal cord stimulation in patients with painful diabetic neuropathy: A multicentre randomized clinical trial. To the authors knowledge, theirs was the 1st multi-center RCT examining the effectiveness of SCS in patients with PDN. The authors concluded that it seems that the SCS for the treatment of the abdominal visceral pain may provide a positive patient long-term experience, significant improvements in pain scores and a decrease in opioid use. Average pain score for all9 patients was 77 at baseline and 34 at 6 months after implantation. A follow-up evaluation was performed at 1 and 3 months with a cross-over washout period of 3 months. Eliasson T, Jern S, Augustinsson L-E, Mannheimer C. Safety aspects of spinal cord stimulation in severe angina pectoris. The Tinetti Mobility Test was also performed in the 2 conditions. Deer and colleagues (2017) stated that animal and human studies indicated that electrical stimulation of DRG neurons may modulate neuropathic pain signals. Spinal cord stimulation for the management of neuropathic pain. Arnhem, The Netherlands: European Association of Urology (EAU); February 2012. A total of 7 patients had SCS applied during the scheduled re-irradiation and chemotherapy for the treatment of recurrent HGG (6 anaplastic gliomas and 1 glioblastoma). The measured increase was 37.7 %, with an estimated potential maximal contribution of the first 18FDGinjection to the quantification of the second PET study (carry-over effect)less than or equal to16.6 %. Novel spinal cord stimulation parameters in patients with predominant back pain. Waltham, MA: UpToDate;reviewed December 2016. Multiple medications, physical therapy, and chiropractic therapy were not successful for this patient. Stocks RA, Williams CT. Spinal cord stimulation for chronic pain. In addition, in a review on the safety and effectiveness of SCS for the treatment of chronic pain, Cameron (2004) stated that SCS had a positive, symptomatic, long-term effect in cases of refractory angina pain, severe ischemic limb pain secondary to peripheral vascular disease, peripheral neuropathic pain, and chronic low-back pain. Links to various non-Aetna sites are provided for your convenience only. 2008;30(6):652-654. Acta Neurotic. The patient reported an immediate improvement in pain because of the introduction of the DRG-SCS. They stated that further trials of other types of neuropathic pain or subgroups of ischemic pain, may be useful. stimwave cpt codemary calderon quintanilla 27 februari, 2023 / i list of funerals at luton crematorium / av Individual cases showed improvement with a variety of etiologies and pain distributions; a subanalysis of post-herniorrhaphy cohort also showed significant improvement. Overall, 16 papers were eligible for this systematic review. 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. 2017;18(12):2401-2421. 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. 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. Amirdelfan et al (2020) noted that intractable neck and upper limb pain has historically been challenging to treat with conventional SCS being limited by obtaining effective paresthesia coverage. London, UK: NICE; October 2008. Pain. A check-list for methodological quality of non-RCTs was used (STROBE check-list) and all review authors discussed and agreed on the inclusion of trials and the results of the quality assessment. The authors concluded that an implanted SCS may be an ideal treatment for intractable meralgia paresthetica after conservative treatments have failed because it is not destructive and can always be explanted without significant permanent adverse effects. 2019;12(9):308-312. Prior conservative therapy, including psychologic treatment, anti-depressants, and opioids, was without any benefits. In addition to a higher proportion of pain responders compared with pharmacotherapy or low-frequency SCS, 10-kHz SCS did not induce paresthesia, an advantage for PDN patients with uncomfortable paresthesia at baseline. Pain (chronic neuropathic or ischaemic) - spinal cord stimulation. Vuka and colleagues (2018) stated that DRG has recently emerged as an attractive target for neuromodulation therapy since primary sensory neurons and their soma in DRGs are important sites for pathophysiologic changes that lead to neuropathic pain. @media print { The authors concluded that in light of limited pharmacologic and non-pharmacologic therapeutic options for patients with neurodegenerative ataxia, and on the basis of the results of this study, a 2-week treatment with cerebello-spinal tDCS could be considered a potentially promising tool for future rehabilitative approaches. Pain therapy user manual for neurostimulation system models 37702, 37711, 37713, 37701, 37712, 37714, 37703, 37704, 37022. outline: none; The data reported were from an RCT in which SCS patients were randomized to either the treatment or control arm, with 79 subjects implanted and followed over the course of 12 months. Follow-up ranged from 5 months to 11 years and 3 months (median of 4 years and 7 months). These researchers stated that the use of successful application of neurostimulation as a therapy has largely been predicated on the principles of patient selection, implantation technique, and stimulation parameters. Furthermore, an UpToDate review on Treatment of chronic pelvic pain in women (Howard, 2013) states that In general, neuromodulation for CPP has not been well-studied. Spinal cord stimulation is not listed in the Summary and Recommendations of this review. The investigators reported that superiority of burst was also achieved (p<0.017). More frequent analysis may be necessary in the first month after implantation. Waltham, MA: UpToDate;reviewed October 2018. Paired t-tests assessed mean percent change from baseline within treatment groups. This observation was supported by the findings of Anderson et al (1994) as well as Eliasson et al (1994). None of the deaths was sudden or unexplained; and this mortality rate was acceptable for such patients. The patient proceeded to implant and received regular programming sessions. } L8685 . Changes from baseline in PDI scores were analyzed using Tukey's pairwise comparisons. top: 0px; Compared to baseline, subjects reported a significant reduction (p < 0.001) in their mean ( standard error of the mean) VAS scores at 12-month assessment for neck pain (7.6 0.2 cm, n = 42 versus 1.5 0.3 cm, n = 37) and upper limb pain (7.1 0.3 cm, n = 24 versus 1.0 0.2 cm, n = 20). Thus, the authors concluded that DRG-SCS could be considered as a reasonable next-step to salvage patients with CRPS who had failed other SCS treatments. These investigators found a long-lasting improvement in 193/346 (55.8 %) MS patients with motor disorders, in 90/134 (67.13 %) MS patients with urinary dysfunction, and in 28/34 (82.35 %) MS patients with neuropathic pain. color: white; Moreover, these researchers stated that these findings warrant further studies with larger patient series and longer follow-ups since this study was a retrospective, single-center study with a short follow-up time of only 1 year and lack of a control group. Can anyone clarify this? At 6-month follow-up, 187 patients were evaluated. Levin K. Cervical spondylotic myelopathy. This patient population has tremendous unmet needs; and this study helped in demonstrating the potential for 10-kHz SCS to provide an alternative pain management approach. Furthermore, to maximize results, an inverse manual search of references cited by identified articles was also performed. However, treatments for pain relief in these patients frequently fail. Ubbink DT, Vermeulen H. Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia. Georgiopoulos M, Katsakiori P, Kefalopoulou Z, et al. Pain Physician. Preliminary results of this study have been presented in abstract form (Hayek, et al., 2015),and study results have been published. The patient was followed-up for 1 year, and his quality of life also was improved via the IBS-Severity Scoring System quality of life tool. Investigators reported neurological improvements, especially improved sensory function, maintained over 12 months for the majority of patients with 10-kHz SCS: 68 % (52 of 76) of subjects originally assigned to SCS and 62 % (32 of 52) of subjects after cross-over. Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: A valuable treatment for chronic failed back surgery patients. hr.separator { Retrospective chart review was completed, including pain ratings on a 100-mm visual analogue scale (VAS) and patient-reported outcomes. Coding & Reimbursement Reference Guides. The same number of electrical pulses and amount of current were delivered in different patterns to allow comparison. 2009;151(11):1419-1425. How will I know if a Freedom Stimulator can help my pain? Pain scores (VAS)before an implant were 8 +/- 1.9 cm, while after the implant 2.49 +/- 1.9 cm. 2021;78(6):687-698. Pain Pract. Rockville, MD: AHRQ; September 2001. Russo and Van Buyten (2015) stated that chronic pain remains a serious public health problem worldwide. An UpToDate review on Meralgia paresthetica (lateral femoral cutaneous nerve entrapment) (Anderson, 2019) does not mention dorsal root ganglion stimulation as a therapeutic option. small french chateau house plans; comment appelle t on le chef de la synagogue; felony court sentencing mansfield ohio; accident on 95 south today virginia Two patients had had amputation of the arm and suffered from phantom limb and stump pain. 2021 Nov 18;16(11):e0260166. Despite a considerable number of ESCS studies, a comprehensive systematic review of ESCS remains unpublished. Reduction in opioid consumption was very significant from a baseline median oral morphine equivalent of 160mg to 26mg (p < 0.001). 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. Spine. Aetna considers a trial of percutaneousdorsal column stimulation medically necessary to predict whether a dorsal column stimulator will induce significant pain relief in members with chronic pain due to any of the following indications when the criteria listedbeloware met: Aetna considers implantation of a dorsal column stimulator (DCS) medically necessary for members who meet the above-listed criteria who haveexperienced significant pain reduction (50 % or more) with a 3- to 7-day trial of percutaneous spinal stimulation.
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