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https://orcid.org/0000-0003-0446-0883
Abstract
Abstract
Purpose
Applying low-intensity extracorporeal shockwave therapy (LI-ESWT) has been reported to improve symptoms of refractory chronic pelvic pain syndrome (CPPS) in short-term follow-up. This study aims to demonstrate the effect of LI-ESWT on refractory CPPS over the span of a 12-month follow-up.
Materials and Methods
This was an open-label, single-arm prospective study. LI-ESWT consisted of 3000 shock waves once weekly for 4 weeks (Duolith SD1 T-Top) were applied. Clinical symptoms were re-assessed at 1, 3, 6, and 12 months using NIH-CPSI score, visual analog scale, 5-item version of the International Index of Erectile Function and International Prostate Symptom Score.
Results
Thirty-one of the 43 patients enrolled had a successful response at the 1-month follow up after the treatment. Twenty-six of the 31 patients who responded successfully to LI-ESWT at the 1-month follow-up, maintained their response at the 6- and 12-month follow-up. The existence of psychosocial disorder at the baseline characteristics analysis was the only potential factor that may hinder the effectiveness of LI-ESWT.
Conclusions
LI-ESWT has shown to be a safe and effective therapy for CPPS patients at the long-term follow-up. History of psychological disorders might be a significant predictor of a successful response.
Introduction
Chronic pelvic pain syndrome (CPPS) is a common urological disorder in men at different ages, with an average prevalence reported approximately 10% [1]. It is a non-specific, poorly localized pelvic pain which causes substantial, negative effects on the patient’s quality of life (QoL), urinary symptoms and even sexual function [2]. According to the National Institute of Health, CPPS is classified as type III of prostatitis, which is characterized by the absence of infective pathogens in expressed prostatic secretions. Although the pathophysiology of CPPS has not yet been fully clarified, it is usually considered multifactorial, with the most common hypothesized etiologies including previous infection, inflammation, pelvic floor muscle dysfunction, perfusion disturbances, neuropathy, and neurobehavioral disorders [3]. A psychiatric factor could possibly play a further role beside the somatic component [4].
The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), which was developed in 1999, helps to construct and validate the evaluation of CPPS patients [5]. It contains scores in three different aspects: urinary symptoms, pain, and QoL. The re-scored questionnaire was also assessed, to provide outcome measurements of men with CPPS, however, challenges still remain due to the complexity of CPPS. A 6-point decrease in the NIH-CPSI total score is regarded as a clinically meaningful improvement in symptoms. In recent years, a phenotypic classification system “UPOINTS” was developed for a more detailed description of seven domains, including urinary (U), psychosocial (P), organ specific (O), infection (I), neurologic/systemic (N), tenderness of muscles (T), and sexual dysfunction (S). Each domain was linked to a specific mechanism, which directs a more individualized, phenotypically based therapeutic approach to maximize the treatment effect in patients with refractory CPPS [6]. However, challenges still remain due to the complexity of CPPS.
In order to cover major physiological etiologies, various therapeutic managements have been proposed. The conventional treatment 3-As medications (antibiotics, non-steroidal anti-inflammatories, and alpha blockers) incorporates a variety of pharmacological approach, rather than monotherapy. As efficient it may seem, up to 46% of CPPS patients still do not sufficiently respond to the first-line treatment [7,8]. A recent meta-analysis reported that treating CPPS as a psychoneuromuscular disorder may significantly surmount this threshold [9]. For patients who are resistant to conventional urological treatment, alternative and complementary managements were developed, including herbal medicines, nutritional supplements, bio-feedback, acupuncture, electrostimulation, hyperthermia, and low-intensity extracorporeal shock wave therapy (LI-ESWT) [10,11].
Shock wave has been frequently used in different domain since 1980, for fragmentation of body concrements and reduction of soft tissue pain [12,13]. Due to its possible influence on treating pain, increasing local perfusion and reducing muscle tone, LI-ESWT has recently been applied in the treatment of CPPS [11], and has shown satisfactory response on clinical symptoms, and QoL in patient refractory to the 3-As medications [14,15]. But the majority of the existing literature focused on short-term follow-up, while the long-term effect of LI-ESWT on patients with CPPS refractory to 3-As medications remains unclear. In this study, we aim to demonstrate the effect of LI-ESWT on CPPS over the span of a 12-month follow-up, and the possible baseline characteristics that may hinder the effectiveness of this treatment.
Material and methods
This open-label, single-arm prospective study was conducted at Kaohsiung Medical University-affiliated hospitals in southwestern Taiwan. Patients with prostatitis category III who were unable to accomplish clinical improvement after receiving 3-As medications between January 2016 and June 2017 were enrolled. Eligible patients were 18 years of age or older and under a stable mental status. The same study protocol was performed as our previous study [14]. All patients received full course and maximal dosage of the 3-As medications, and failed to achieve more than 6-point decrease in the total score of NIH-CPSI for at least 3 of the preceding 6 months. All patients were accessed initially with a structured questionnaire for collecting detailed demographic information and thorough medical, surgical, psychological, and sexual history. Comorbidities and risk factors for CPPS were reviewed. Routine blood variables (including total testosterone, creatinine, fasting glucose, and lipid profile) and prostate-specific antigen were also collected. Before the LI-ESWT treatment period, all patients undergone sufficient education by a urologist, clinical phenotyping with UPOINTS were re-accessed and corrected before enrolling in this study. Prostate cancer was excluded clinically and serologically prior to the therapy. Other exclusion criteria for this study included significant coagulopathy, anatomical abnormalities of perineal area, neurological abnormalities, history of extensive pelvic injuries.
Treatment protocol
The study protocol was authorized by the Institutional Review Board of Kaohsiung Medical University Hospital. Eligible patients signed informed consent. All participants were treated by LI-ESWT (Duolith SD1 T-TOP, Storz, Tägerwilen, Switzerland) once a week for 4 weeks. The patients received a total of 3000 impulses, with 0.25 mJ/mm2 at a frequency of 4 Hz delivered on the perineum at six different anatomical sites (500 impulses per site) at each treatment session (Figure 1). During the LI-ESWT treatment course, alpha blocker, and anti-inflammatories dose tapering were allowed according to the clinical condition. The treatment was performed without local or systemic anesthesia in an outpatient setting.
Published online:
04 April 2019![]({"type":"image","src":"/na101/home/literatum/publisher/tandf/journals/content/itam20/2020/itam20.v023.i05/13685538.2019.1597341/20210528/images/medium/itam_a_1597341_f0001_c.jpg"})
Figure 1. LI-EWST at six different anatomical sites (500 impulses per site).
Outcome measurements
Baseline evaluation for symptoms of each participant was assessed using validated questionnaires, including NIH-CPSI score, International Prostate Symptom Score (IPSS), Visual Analog Scale (VAS), and Erectile Hardness Score. Clinical outcomes were reassessed at 1, 3, 6, and 12 months (W8, W16, W28, and W52 showed in table and figure, respectively) after a complete course of LI-ESWT. A 6-point or more decrease in the NIH-CPSI total score was defined as successful response to the therapy [16]. Any adverse event associated with LI-ESWT during the treatment was recorded.
Statistical analysis
The quantitative data were represented as mean value plus or minus standard deviations, and categorical values depict as numbers (n) and percentages. Statistical analyses such as chi-square test and Fisher’s exact test were used to quantify the difference between subjects with and without response to LI-ESWT. Student’s t-test was applied for comparing continuous variables. A p < 0.05 was considered statistically significant for all analysis. Data were analyzed using SPSS version 18 (International Business Machines Corporation (IBM), Armonk, NY, US).
Results
From January 2016 to June 2017, a total of 43 refractory CPPS patients with a mean age of 45.91 ± 14.18 years old were enrolled in this study. The mean duration of CPPS period was 26.22 (range: 6–360) months, including 23 patients with CPPS IIIa and 20 patient with CPPS IIIb. The baseline characteristics and comorbidities are listed in Table 1.
Table 1. Baseline characteristics of study population (N = 43).
At 1 month follow-up after LIESWT (W8), 31 patients (72.1%) had a 6 or more decline in the NIH-CPSI total score. Over the span of a 12-month follow-up, the mean of NIH-CPSI subscales, VAS and IPSS also showed statistical improvement after the LI-ESWT course (Table 2; Figure 2). By the time at 1 year after LIESWT, 75.68% (28 patients) had medication tapering and only 40.54% (15 patient) under painkiller use. Of the 31 patients who showed well response to LI-ESWT at the 1-month follow up, 26 patients (83.9%) could maintain their response at the 6- and 12-month follow-up. Total six patients lost follow-up during the study period, which may be due to complete resolution (Figure 3). During the treatment and follow-up period, no side-effects associated with LI-ESWT, such as ecchymosis, hematuria, or hemospermia were observed in any patients.
Published online:
04 April 2019Figure 2. Improvement of clinical symptoms in subjects at the 1, 3, 6, and 12 month follow-up. #n = 37, 6 cases lost follow up at 6 months after LI-ESWT.
![]({"type":"image","src":"/na101/home/literatum/publisher/tandf/journals/content/itam20/2020/itam20.v023.i05/13685538.2019.1597341/20210528/images/medium/itam_a_1597341_f0002_c.jpg"})
Figure 2. Improvement of clinical symptoms in subjects at the 1, 3, 6, and 12 month follow-up. #n = 37, 6 cases lost follow up at 6 months after LI-ESWT.
Published online:
04 April 2019Figure 3. The improvement of clinical symptoms over the span of a 12-month follow-up in 31 subjects with successful response at the 1-month follow-up, #n = 27, 4 cases lost follow up at 6 months after LI-ESWT.
![]({"type":"image","src":"/na101/home/literatum/publisher/tandf/journals/content/itam20/2020/itam20.v023.i05/13685538.2019.1597341/20210528/images/medium/itam_a_1597341_f0003_c.jpg"})
Figure 3. The improvement of clinical symptoms over the span of a 12-month follow-up in 31 subjects with successful response at the 1-month follow-up, #n = 27, 4 cases lost follow up at 6 months after LI-ESWT.
Table 2. Change of clinical symptoms after LI-ESWT (N = 43).
The characteristics between patients with and without response to LI-ESWT at the 1-month follow-up were analyzed in Table 3. Subjects with history of psychological disorders had a significantly low response rate to LI-ESWT (p = 0.028). All other characteristics, such as age, body mass index, common morbidities, life style, or laboratory data revealed no significant difference.
Table 3. Comparison of clinical characteristics and laboratory data between subjects with and without response to LI-ESWT at the 1-month follow-up.
Discussion
CPPS endures of complicated etiologies, which makes satisfactory and sufficient treatment difficult. LI-ESWT has been applied as a therapeutic equipment and has shown satisfactory response according to the literature reviewed since 2008. But most of the research focused on short-term (3–6 months) effect of LI-ESWT on CPPS, except for one research with long-term (12 months) follow-up [17]. In the leading two studies by Zimmerman et al., the first [18] showed statistically significant in QoL and pain 12 weeks after completed LI-ESWT, while voiding conditions were only temporarily improved without statistical significance. The latter study [19] was the first prospectively randomized, double-blind study which revealed statistically significant improvement of pain, QoL, and voiding conditions at 12-week following LI-ESWT in comparison to the placebo group. Our previous short-term study also supported the safety and efficacy of LI-ESWT in patient refractory to the 3-As medications [14].
In this prospective study involving men with CPPS refractory to the traditional 3-As medications, the long-term efficacy of combined treatment with LI-ESWT was evaluated. After completing the course of LI-ESWT, 72.1% patients (31 out of all 43 subjects) showed significant improvement at the 3-month follow up. Of the 31 patients who showed well response to LI-ESWT at the short-term follow up, 26 patients (83.9%) still continued the therapeutic efficacy at the 12-month follow-up. The persistence positive effect was observed across all aspects, including IPSS, VAS, NIH-CPSI total score and subscales (Table 2). This finding was concordance with our previous study [14], which revealed up to 81.85% of refractory patients with CPPS could achieve a clinical significant improvement at the 3-month follow up after the LI-ESWT treatment. No obvious side effects were noted during and after the application of LI-ESWT.
The therapeutic mechanism of LI-ESWT on CPPS had been discussed recently. LI-ESWT could induce neovascularization process, further associate pain alleviation and tissue healing. LI-ESWT also could induce hyperstimulation of nociceptors, which intended to interrupt the flow of nerve impulse [20]. On the one hand, LI-ESWT reduces muscle tone, by inducing enzymatic and non-enzymatic nitric oxide (NO) synthesis [21], which involves in the peripheral and central nervous system. It is also suggested that NO synthesis is one of the most important physiologically important mechanisms that could explain the effectiveness of LI-ESWT in anti-inflammatory treatment [22,23]. Another possible mechanism that LI-ESWT could recruit endogenous mesenchymal stem cells to regenerate neuronal nitric oxide synthase (nNOS)-positive nerves, endothelium, and smooth muscle in a diabetes mellitus rat model was also demonstrated [24]. Based on these hypothesized mechanisms, LI-ESWT appears to covers several aspects of UPOINTS, including urinary, organ specific, neurologic, tenderness, and sexual dysfunctions. Traditional 3-As medications may be applied for treating infection and tenderness. However, both treatment fails to encompass the psychosocial domain. This supports our finding during the baseline characteristic evaluation, which revealed a statistically significant difference in psychosocial aspect between the response and non-response group. In our study, while comparing the baseline characteristics, psychosocial disorder was shown to be the possible aspect that may hinder the effectiveness of this treatment.
However, there are some limitations in our study. First, the sample size was relatively small, making comparison for different etiologies of CPPS difficult. The study was also performed as a single-arm design. These efficacies of LI-ESWT might not assess correctly due to the placebo effect. Total six patients lost follow-up during the study period. The discrepancy also could verify the effectiveness of LI-ESWT for CPPS, even in an extended period of time. Second, all subjects could not unify their oral medicine after LI-ESWT. To elucidate the precise efficacy of LI-ESWT in the treatment of patients with refractory CPPS, further more large-scale, double-blind studies are clearly needed.
In conclusion, LI-ESWT has shown to be a safe and effective therapy for CPPS patients who failed to respond to traditional 3-As therapy. For patients with successful response to LI-ESWT at the short-term follow-up, the clinically significant improvement as a result of this treatment was still noticeable at the 1-year follow-up. The existence of psychosocial disorder at the baseline characteristics analysis was a potential factor that may hinder the effectiveness of LI-ESWT.
| Parameter | N (%) | Mean (±SD) | Range |
|---|---|---|---|
| Age (year) | 45.91 (14.18) | (23–72) | |
| Body mass index (kg/m2) | 24.35 (3.04) | (18.72–32.22) | |
| Waist circumference (cm) | 86.65 (7.36) | (73–107) | |
| CPPS period (month) | 46.22 (61.47) | (6–360) | |
| CPPS category | |||
| CPPS IIIa | 23 (53.5) | ||
| CPPS IIIb | 20 (46.5) | ||
| Comorbidities and life style | |||
| Genitourinary tract infection | 26 (60.47) | ||
| Pelvic organ surgery or trauma | 9 (20.93) | ||
| Psychological disorder | 8 (18.60) | ||
| Diabetes mellitus | 2 (4.65) | ||
| Hypertension | 9 (20.93) | ||
| Hyperlipidemia | 11 (25.58) | ||
| Cardiovascular disease | 3 (6.98) | ||
| Peripheral or central neuropathy | 4 (9.30) | ||
| Sleep disorder | 27 (62.79) | ||
| Hypogonadism | 10 (23.26) | ||
| Current smoking | 18 (41.86) | ||
| Current alcohol drinking | 15 (34.88) | ||
| Current betel nut chewing | 3 (6.98) | ||
| Regular sexual activity | 31 (72.09) | ||
| Regular exercise habits | 19 (44.19) | ||
| Laboratory data | |||
| Total testosterone (ng/dl) | 520.23 (179.63) | (220.00–863.30) | |
| Prostate specific antigen (ng/ml) | 1.56 (1.74) | (0.3–8.0) | |
| Creatinine (mg/dl) | 0.94 (0.17) | (0.6–1.5) | |
| Alanine aminotransferase (mg/dl) | 25.79 (8.69) | (13–56) | |
| Fasting sugar (mg/dl) | 101.72 (21.62) | (78–214) | |
| Triglycerides (mg/dl) | 121.37 (46.68) | (50–239) | |
| Total Cholesterol (mg/dl) | 182.77 (33.57) | (97–264) | |
| High density lipoprotein (mg/dl) | 46.90 (13.04) | (30.8–107.0) | |
| Low density lipoprotein (mg/dl) | 111.46 (26.57) | (36.10–169.60) | |
| History of medicine | |||
| Antibiotics(month) | 3.45 (3.05) | (1.5–15) | |
| Anti-inflammatory | 12.33 (19.30) | (1–120) | |
| α-blocker | 25.74(42.66) | (1.5–240) |
CPPS: chronic pelvic pain syndrome; SD: standard deviation.
| Parameter | Baseline | After LI-ESWT | |||||||
|---|---|---|---|---|---|---|---|---|---|
| W0 | W8 | W16 | W28a | W52a | |||||
| (N = 43) | (N = 43) | Difference | (N = 43) | Difference | (N = 37) | Difference | (N = 37) | Difference | |
| NIH-CPSI, Mean (±SD) | – | – | – | – | – | ||||
| Total score | 28.51 (6.08) | 19.79 (8.91) | 8.72 ± 6.69* | 16.53 (8.89) | 11.98 ± 8.74* | 17.22 (9.28) | 11.46 ± 8.74* | 17.41 (10.50) | 11.27 ± 9.78* |
| Pain subscales | 13.05 (2.96) | 8.02 (4.81) | 5.02 ± 3.97* | 6.37 (4.53) | 6.67 ± 4.06* | 6.81 (4.53) | 6.35 ± 4.58* | 7.27 (5.03) | 5.89 ± 5.10* |
| Urinary subscales | 6.02 (2.43) | 4.28 (2.66) | 1.74 ± 2.18* | 3.95 (2.59) | 2.07 ± 2.96* | 4.24 (2.67) | 1.95 ± 2.28* | 4.03 (2.93) | 2.16 ± 2.50* |
| QoL subscales | 9.44 (2.07) | 7.49 (2.81) | 1.95 ± 2.56* | 6.21 (2.85) | 3.23 ± 3.05* | 6.19 (3.12) | 3.14 ± 3.24* | 6.11 (3.25) | 3.22 ± 3.30* |
| NIH-CPSI decline≧6, n (%) | NA | 31 (72.09) | 33 (76.74) | 31 (83.78) | 26 (70.27) | ||||
| VAS, Mean (±SD) | 5.72 (1.58) | 3.28 (2.49) | 2.44 ± 2.15* | 2.60 (2.30) | 3.12 ± 2.14* | 3.00 (2.42) | 2.84 ± 2.36* | 3.14 (2.55) | 2.70 ± 2.48* |
| IPSS, Mean (±SD) | 15.30 (8.39) | 10.23 (8.11) | 5.07 ± 4.62* | 9.93 (7.68) | 5.37 ± 5.36* | 11.00 (8.43) | 4.35 ± 6.21* | 10.92 (8.98) | 4.43 ± 6.66* |
| EHS, Mean (±SD) | 3.16 (0.92) | 3.49 (0.67) | −0.33 ± 0.78* | 3.47 (0.80) | −0.30 ± 0.77* | 3.32 (0.88) | −0.19 ± 0.91 | 3.38 (0.89) | −0.24 ± 0.80 |
| Medication tapering, n (%) | NA | 35 (81.40) | 35 (81.40) | 30 (81.80) | 28 (75.68) | ||||
| Painkiller use, n (%) | NA | 24 (55.81) | 18 (41.86) | 15 (40.54) | 15 (40.54) | ||||
EHS: Erection Hardness Score; IELT: intravaginal ejaculation latency time; IPSS: International Prostate Symptom Score; LI-ESWT: low-intensity extracorporeal shock wave therapy; NIH-CPSI: National Institutes of Health-Chronic Prostatitis Symptom Index; QoL: quality of life; SD: standard deviation; VAS: Visual Analog Scale.
a n = 37, 6 cases lost follow up at 6 months after LI-ESWT.
* The p values of difference between baseline <0.05.
| Parameter | Subjects without response (N = 12) | Subjects with response (N = 31) | p value |
|---|---|---|---|
| Age (year), Mean (±SD) | 45.00 (16.15) | 46.26 (13.61) | 0.798 |
| Body mass index (kg/m2), Mean (±SD) | 24.33 (3.36) | 24.36 (2.96) | 0.976 |
| Waist circumference (cm), Mean (±SD) | 87.92 (8.47) | 86.16 (6.97) | 0.490 |
| CPPS period (months), Mean (±SD) | 50.38 (53.17) | 44.61 (65.15) | 0.787 |
| CPPS category, n(%) | 0.281 | ||
| CPPS IIIa | 8 (66.67) | 15 (48.39) | |
| CPPS IIIb | 4 (33.33) | 16 (51.61) | |
| Comorbidities, n(%) | |||
| Genitourinary tract infection | 7 (58.33) | 19 (61.29) | >0.999 |
| Pelvic organ surgery or trauma | 3 (25.00) | 6 (19.35) | 0.692 |
| Psychological disorder | 5 (41.67) | 3 (9.68) | 0.028* |
| Diabetes mellitus | 0 (0.00) | 2 (6.45) | NA |
| Hypertension | 1 (8.33) | 8 (25.81) | 0.405 |
| Hyperlipidemia | 2 (16.67) | 9 (29.03) | 0.698 |
| Cardiovascular disease | 1 (8.33) | 2 (6.45) | >0.999 |
| Peripheral or central neuropathy | 0 (0.00) | 4 (12.90) | NA |
| Hypogonadism | 2 (16.67) | 8 (25.81) | 0.698 |
| Current smoking | 3 (25.00) | 15 (48.39) | 0.163 |
| Current alcohol drinking | 5 (41.67) | 10 (32.26) | 0.723 |
| Current betel nut chewing | 1 (8.33) | 2 (6.45) | >0.999 |
| Sleep disorder | 8 (66.67) | 19 (61.29) | >0.999 |
| No regular excercise | 5 (41.67) | 19 (61.29) | 0.245 |
| No regular sex | 84 (33.33) | 8 (18.60) | 0.711 |
| Number of comorbidities, Mean (±SD) | 3.92 (2.07) | 4.32 (2.18) | 0.582 |
| History of medicine (month), Mean (±SD) | |||
| Antibiotics | 3.54 (3.85) | 3.42 (2.76) | 0.908 |
| Anti-inflammatory | 19.96 (33.53) | 9.38 (8.78) | 0.303 |
| α-blocker | 25.75 (35.32) | 25.73 (45.72) | 0.999 |
| Laboratory data, Mean (±SD) | |||
| Total testosterone (ng/dl) | 537.60 (178.50) | 513.50 (182.60) | 0.698 |
| Prostate specific antigen (ng/ml) | 1.97 (2.36) | 1.40 (1.45) | 0.446 |
| Creatinine(mg/dl) | 0.92 (0.20) | 0.94 (0.16) | 0.737 |
| Alanine aminotransferase(mg/dl) | 28.42 (9.38) | 24.77 (8.35) | 0.222 |
| Fasting sugar(mg/dl) | 99.17 (10.47) | 102.70 (24.71) | 0.513 |
| Triglycerides(mg/dl) | 117.60 (39.41) | 122.80 (49.73) | 0.745 |
| Total Cholesterol(mg/dl) | 191.00 (36.41) | 179.60 (32.47) | 0.323 |
| High density lipoprotein(mg/dl) | 51.48 (20.43) | 45.14 (8.56) | 0.318 |
| Low density lipoprotein(mg/dl) | 117.50 (24.91) | 109.10 (27.21) | 0.358 |
| Initial clinical severity, Mean(±SD) | |||
| NIH-CPSI | |||
| Total score | 30.08 (6.56) | 27.90 (5.88) | 0.297 |
| Pain subscales | 13.25 (3.28) | 12.97 (2.88) | 0.783 |
| Urinary subscales | 6.67 (2.53) | 5.77 (2.39) | 0.286 |
| QoL subscales | 10.17 (2.37) | 9.16 (1.92) | 0.156 |
| VAS | 5.75 (2.05) | 5.71 (1.40) | 0.941 |
| IPSS | 18.67 (8.39) | 14.00 (8.14) | 0.102 |
| EHS | 3.00 (1.21) | 3.23 (0.80) | 0.479 |
EHS: Erection Hardness Score; IPSS: International Prostate Symptom Score; LI-ESWT: low-intensity extracorporeal shock wave therapy; NIH-CPSI: National Institutes of Health-Chronic Prostatitis Symptom Index; QoL: quality of life; SD: standard deviation; VAS: Visual Analog Scale.
Disclosure statement
No potential conflict of interest was reported by the authors.
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