Closure operators and systems play a significant role in a variety of areas of fuzzy logic. While the condition of monotony for ordinary closure operators has a straightforward form, two basic conditions of monotony naturally arise from the existing examples in a fuzzy setting. To unify these two conditions, two approaches can be found in the literature, one based on the notion of a filter of truth degrees and the other on the notion of a linguistic hedge. We present results connecting these approaches, explore their variants, and provide a notion of monotony that subsumes both the filter-based and hedge-based approaches. We study properties of this general concept of monotony and discuss open problems along with topics for future research.

Complex anal fistulas remain a therapeutic challenge due to high recurrence rates and the risk of incontinence associated with conventional treatments. Microfragmented autologous adipose tissue has emerged as a sphincter-sparing option with potential regenerative and anti-inflammatory properties. This study aimed to evaluate the safety and efficacy of its injection into the fistula tract combined with closure of the internal opening. A single-center, retrospective, observational study was conducted between June 2019 and May 2025. All patients with complex anal fistulas treated with microfragmented adipose tissue processed with LIPOGEMS® system were included. Demographic data, fistula characteristics, surgical history, perioperative variables, postoperative morbidity, healing rate, and hospital stay were analyzed. Follow-up visits were performed weekly in the first month, and at 3, 6 and 12 months thereafter. A total of 28 patients with complex fistula were included. Mean patient age was 51.2 years (SD: 15.3), with predominance of males (69.7%). Most fistulas were medium or high transsphincteric (85.7%) and the main location was posterior (57.1%). 75% of patients had undergone previous curative-intent procedures. Median operative time was 71 minutes, and median processed adipose volume was 14 ml. Two postoperative complications were recorded (one abdominal hematoma-CD I and one perianal abscess-CD IIIa). After a median follow-up of 11.2 months, the overall healing rate was 46.4%, higher in primary (57.1%) and posterior fistulas (56.3%). Median hospital stay was one day, and median clinical closure occurred at 2.7 months. LIPOGEMS® therapy appeared safe, feasible, and associated with encouraging healing outcomes, offering advantages in functional preservation and recovery. Larger prospective studies are needed to confirm these results and refine its role in fistula management.

Inner ear malformations can cause abnormal communication between the inner ear and subarachnoid space, leading to otogenic cerebrospinal fluid (CSF) leakage and subsequent bacterial meningitis. Persistent leakage may result in recurrent meningitis, which is associated with neurological sequelae and poor prognosis; thus, early diagnosis and surgical intervention are essential. Various surgical strategies have been reported, commonly termed middle ear obliteration and inner ear obliteration. However, their definitions remain ambiguous, and techniques vary widely in approach and effectiveness. This study describes 2 pediatric cases of incomplete partition type I (IP-I) malformation complicated by recurrent meningitis that were treated with translabyrinthine fistula closure via the lateral semicircular canal, a form of inner ear obliteration. Both patients exhibited high vestibular CSF pressure due to hypoplasia of the internal auditory canal fundus. Patient 1 had undergone 4 previous window closure surgeries elsewhere without success, whereas Patient 2 had no residual hearing and required prompt management. In both cases, the fistula was directly identified and sealed with a three-layer construct under direct visualization, allowing secure closure. Postoperative follow-up revealed no recurrence of meningitis for >8 years in Case 1 and more than 1 year in Case 2, without complications. This technique may represent a reasonable treatment option for controlling CSF leakage in severe inner ear malformations, including cases refractory to conventional treatments, even at the cost of sacrificing inner ear function. Using 2 representative pediatric cases, this study presents a case-based review that clarifies the classification, indications, and limitations of current surgical strategies for otogenic CSF leakage associated with inner ear malformations.

IntroductionDiverting loop ileostomy (DLI) after low anterior resection for rectal cancer reduces the clinical consequences of anastomotic leakage but is associated with significant morbidity, impaired quality of life and the need for a second operation for stoma closure. Temporary intraluminal bypass devices have been developed to protect the anastomosis while avoiding DLI. However, high-quality prospective data comparing such devices with standard DLI remain limited. This study aims to evaluate the safety and effectiveness of the Colovac device compared with DLI.Methods and analysisSafeHeal Studies (SAFE-3), consisting of SafeHeal Standard of Care (Diverting Ileostomy) study (SH-SOC23) and SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study (SAFE-3CV), is an international, multicentre, prospective, non-randomised comparative study comprising two sequential cohorts: SH-SOC23 (standard-of-care diverting ileostomy control) and SAFE-3CV (Colovac anastomosis protection device). A total of 233 patients will be enrolled (SAFE-3CV n=108–120; SH-SOC23 n=132) across 25 centres in 4 countries. The primary endpoints are the rate of major complications at 9 months for safety and stoma avoidance at day 10 for effectiveness. Secondary outcomes include overall postoperative morbidity, stoma-related complications, reoperation rates, length of stay and stoma avoidance. Sample size calculation is based on non-inferiority assumptions. Data will be analysed using intention-to-treat principles, with propensity score adjustment to account for baseline differences between cohorts. Comparative analyses will include logistic regression and sensitivity analyses.Ethics and disseminationThe study was approved by ethics committees at the country level or at individual sites as per individual country requirements. An independent safety monitoring committee regularly reviews adverse events and safety data throughout the study. Results will be disseminated through peer-reviewed publications and presentations at international meetings.Trial registration numbersSH-SOC23: NCT06152276 and SAFE-3CV: NCT07116668.

Second-intention healing (SIH) has been a cornerstone of Mohs micrographic surgery (MMS) for defect closure. However, advancements in reconstructive techniques have reduced its use, despite evidence supporting its efficacy in appropriately selected cases. Although physician-reported outcomes are well established, patient-reported (PR) perspectives on SIH remain underexplored. To systematically review patient satisfaction and reported outcomes after SIH in MMS. A systematic literature search was conducted in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines, using databases including PubMed and EMBASE. Studies assessing PR satisfaction, cosmetic outcomes, healing experiences, and functional results of SIH after MMS were included. Data extraction and quality assessment were performed independently by 2 reviewers (C.H. and C.P.). Eight studies met the inclusion criteria. PR satisfaction/outcomes with SIH were high, with favorable cosmetic and functional outcomes. Minor complications were reported, but did not significantly affect overall satisfaction. However, variability in outcome assessment methods, particularly the use of nonvalidated scoring systems, limits comparability across studies. SIH remains a valuable reconstructive option in MMS, offering high patient satisfaction in select cases. Standardization of PR outcome measures is needed to enhance comparability and optimize decision making in dermatologic surgery.

The Management of Myelomeningocele Study established a role for maternal-fetal surgery for myelomeningocele (MMC) but was limited to patients with a maternal body mass index (BMI) less than 35 kg/m 2 . However, as the rate of obesity has increased globally, some centers have extended the Management of Myelomeningocele Study criteria to include patients with a BMI of 35 to 40 kg/m 2 . We used the Fetal MMC Consortium registry to analyze the complications associated with maternal-fetal surgery in patients with a maternal BMI < 35 kg/m 2 compared with 35 to 40 kg/m 2 . The prospective observational Fetal MMC Consortium registry sponsored by the North American Fetal Therapy Network was used to extract deidentified "maternal complication" and "fetal/neonatal complication" data sets, corresponding to patients with complete entries related to maternal or fetal/neonatal complications, respectively. Demographics, clinical characteristics, and complications were recorded. Propensity score matching was conducted with a 2:1 algorithm, and outcomes were compared between patients with BMI < 35 kg/m 2 and those with BMI 35 to 40 kg/m 2 . Propensity score matching resulted in 156 patients with BMI < 35 kg/m 2 and 78 patients with BMI 35 to 40 kg/m 2 in the "maternal complication" data set, and 130 patients with BMI < 35 kg/m 2 and 65 patients with BMI 35 to 40 kg/m 2 in the "fetal/neonatal complication" data set. No significant differences in the median number of maternal (2.0 vs 2.0; P = .257) or median number of fetal/neonatal (1.0 vs 1.0; P = .409) complications were observed between the 2 cohorts. Furthermore, prematurity rates did not differ significantly between the BMI < 35 and BMI 35 to 40 cohorts. Maternal-fetal surgery for open neural tube defect closure is not associated with increased risks among patients with a maternal BMI of 35 to 40 kg/m 2 . Extending the initial inclusion criteria for prenatal MMC closure has the potential to expand access to patients with a higher risk for open neural tube defects.

Reliable discharge estimation is essential for water resource management, yet many regions lack sufficient hydrological stations. To address this limitation, we propose the Spatial Hydraulic Geometry Interpolation (SHGI) method, which estimates discharge (Q), hydraulic depth (D), and mean velocity (V) from river width (W) obtained via surveys or satellite imagery. SHGI integrates hydraulic geometry theory with multiquadric radial basis interpolation, applied to the Meta and Atrato river basins in Colombia. Parameters of at‑station hydraulic geometry (coefficients , c, k and exponents b, f, m) were derived using least squares and transformed into log‑ratio space to preserve their compositional constraints. Interpolation along upstream distance ensures spatial continuity, and closure operations guarantee internal consistency. Validation against observed data in basins with contrasting geomorphology and data density confirmed the method's robustness. The principal contributions of SHGI are:•Longitudinal continuity: explicit incorporation of upstream distance to interpolate parameters consistently along channels and tributaries.•Compositional integrity: preservation of the multiplicative and additive constraints of hydraulic geometry parameters during interpolation.•Estimation under data scarcity: enabling calculation of Q, D, and V at ungauged sites using only river width.

Complex cryptoglandular anal fistulas present a treatment challenge, with many surgical options associated with recurrence, variable healing rates, and risk of incontinence. Freshly collected autologous adipose tissue (FCAAT) has been proposed as a minimally invasive, one-step alternative. This study aimed to assess clinical healing and clinical improvement and to evaluate the safety of the procedure. This prospective cohort study included 31 patients without inflammatory bowel disease (IBD) with complex single-tract cryptoglandular anal fistulas treated with FCAAT between May2019 and December 2023 and followed until August 2024. The surgical procedure involved liposuction, processing of adipose tissue,closure of the internal opening, and local injection along the fistula tract in a one-step procedure. Primary outcomes were clinical healing and clinical improvement; secondary outcomes were adverse events. The patient cohort presented with advanced disease. Median disease duration was 20months, and one-third of patients had undergone previous attempts at surgical closure. Clinical healing was achieved in 23 patients (74%), with an additional four patients (13%) demonstrating clinical improvement. Five of 27 responders (19%) healed more than 3months post-procedure. Common adverse events included proctalgia in 8 patients (22%), donor site pain 5 (14%), and minor graft site hematomas in 4 (11%). One Clavien-DindoIIIa event (graft site bleeding) was managed with a single suture; all other complications were minor and resolved conservatively. FCAAT is a safe and effective one-step treatment for complex anal fistulas in non-IBD patients, offering a high healing rate with predominantly minor complications. A delayed effect was observed in some patients.

The treatment of anal fistula remains a delicate balance between achieving healing and preserving anal continence. Sphincter-preserving strategies, such as autologous platelet-rich plasma/fibrin (PRP/PRF) matrices, offer a regenerative approach with minimal morbidity. This study aims to evaluate the efficacy and safety of a specific autologous fibrin matrix system (Obsidian RFT) in the management of anal fistula and to identify predictors of treatment success. We conducted a retrospective analysis of patients treated with the Obsidian RFT system for anal fistula at a single institution between January 2020 and September 2025. The primary endpoint was fistula healing, defined as the complete cessation of drainage and closure of the external opening. Secondary endpoints included secondary healing (after a simple adjunctive procedure), overall final healing (after any reintervention), and postoperative fecal incontinence (Wexner score). A subgroup analysis was performed to evaluate outcomes in "ideal candidates" (single-tract, non-supralevator fistulas, no associated abscess). A total of 86 patients were included (mean age 52.4 ± 14.4years; 64% male). The majority of fistulas were transsphincteric (96.5%). The median follow-up was 8.7months. Primary healing was achieved in 45.3% of patients (39/86) after the first application. With the addition of a simple secondary procedure (repeat matrix application or limited fistulotomy), the secondary healing rate increased to 58.1% (50/86). Overall final healing, including patients requiring complex reinterventions, reached 64.0% (55/86). Persistence accounted for most failures, while true late recurrence was uncommon. Postoperative fecal incontinence was rare, occurring in only 2.3% of patients. In the "ideal patient" subgroup, primary healing was significantly higher (51.4%) compared to non-ideal candidates (18.8%; p = 0.018), rising to 65.7% with reintervention (p = 0.003). The Obsidian RFT system is a safe, sphincter-preserving option associated with minimal morbidity and negligible impact on continence.While primary healing rates are modest, the cumulative success rate significantly increases with a sequential approach, validating its use as a "staged" strategy.This modality serves as a valuable first-line treatment in a stepped-care algorithmto minimize incontinence riskbefore escalating to more invasive procedures.

In this paper, we introduce novel concepts that represent unique contributions to the framework of supra soft topological spaces. First, we define and characterize the notion of feeble α-supra open soft subsets, establishing their fundamental properties. Through illustrative examples, we demonstrate the relationships between this class of soft subsets and existing generalizations of supra open soft sets. Then, we put forward the concepts of interior, closure, frontier, and accumulation operators induced by the class of feeble α-supra open soft and α-closed subsets, deriving their key properties and establishing fundamental relationships through some formulas

As the Hainan Free Trade Port (FTP) moves toward full closure operations, industrial sectors in Haikou face an urgent demand for personnel equipped with robust vocational English competence (VEC). This paper examines the structural misalignment between existing higher vocational English education and the authentic occupational language needs of Haikou’s dominant industries. Drawing on stakeholder theory, foreign language education planning theory, and a core competence framework, the study proposes a “Government-Industry-Enterprise-School” (GIES) four-party collaborative cultivation mechanism. Central to this mechanism is a three-dimensional VEC model comprising language proficiency, occupational competence, and intercultural communication capacity. The paper argues that effective cultivation requires simultaneous restructuring of programme objectives, modular curriculum design, dual-supervisory practicum systems, and enterprise-led multi-dimensional assessment. Implications for policy, curriculum reform, and teacher development in free trade port contexts are discussed.

The paper is devoted to a categorical study of the category ProbMet of probabilistic metric spaces. The study is based on an isomorphic description of the category of probabilistic metric spaces. The isomorphic description was obtained in [3] and is in terms of objects that are sets endowed with a collection of distances, where the distances involved do not satisfy the triangle inequality but fulfil a mixed triangle condition instead. The morphisms are levelwise non-expansive maps. We show that the category of probabilistic metric spaces is a monotopological category over Set. We describe the regular closure on a space X in ProbMet and prove that it coincides with the closure in the underlying strong topology. This enables us to characterize the class of all epimorphisms as the dense maps and the class of all regular monomorphisms as the closed embeddings in terms of the closure operator. We prove that the category Met ∞ of extended metric spaces with non-expansive maps is both coreflectively and reflectively embedded in ProbMet.

We introduce the transitive closure operator Γ on the set of square matrices over a class of semirings, and then define the transitive closure of a matrix. We characterize the surjective linear transformations of matrices preserving (strongly preserving) transitive closures, and show that a surjective linear transformation preserves the transitive closures if and only if it commutes with Γ, which is equivalent to preserving the kernel of Γ. We also deduce that the strong linear preservers of transitive closure on 2×2 matrices over certain inclines are surjective. In particular, we provide a complete characterization of strong linear preservers of transitive closure on n×n matrices over the binary Boolean semiring.

The treatment of Crohn's perianal fistula remains challenging owing to its recurrent nature and resistance to complete healing. This study aimed to assess the postoperative outcomes, including fistula closure rates, following Crohn's perianal fistula surgery, with and without polydeoxyribonucleotide administration. A retrospective review was conducted on patients who underwent fistula closure operations for Crohn's perianal fistula at a single tertiary center in Seoul, Korea, between January 2018 and June 2024. Patients were divided into two groups based on the use of local polydeoxyribonucleotide (PDRN) injections during fistula closure operations, and clinical variables and postoperative outcomes were compared between the groups. Among the 47 patients, 21 (44.7%) were assigned to the PDRN group and 26 (55.3%) were assigned to non-PDRN group. Baseline characteristics between the two groups showed no significant difference. During the mean follow-up of 30.4 months, patients in the PDRN group demonstrated a significantly higher complete fistula closure rate (70.0% vs 26.9% at 6 months, and 83.3% vs 46.2% at 12 months; P = .005), and a shorter time from surgery to complete closure (3.3 ± 2.6 months vs 5.9 ± 3.8 months; P = .044), compared with the non-PDRN group. Multivariate analysis revealed PDRN as an independent factor significantly associated with Crohn's perianal fistula closure (HR 2.336; 95% CI, 1.092-4.997, P = .029). PDRN is a potential therapeutic agent that presents a viable option for Crohn's perianal fistula surgery, improving complete fistula closure rate through a safe, cost-effective, and relatively simple procedure.

Giant condyloma acuminatum (GCA), or Buschke–Löwenstein tumor (BLT), is a rare HPV-associated verrucous lesion that exhibits locally aggressive behavior despite often having a benign histology. We report the case of a 46-year-old patient with no significant past medical history, presenting with a large verrucous lesion that had been evolving for 10 years, extending from the scrotum to the posterior perineum and into the perianal region. Rectocolonoscopy revealed no abnormalities. Pelvic MRI showed a nodular parietal thickening involving the scrotum, inguinal regions, and perianal region, measuring approximately 60 × 170 mm. Complete multidisciplinary surgical excision was performed in collaboration with the colorectal surgeons, combined with a protective colostomy, followed by secondary closure surgery. The outcome was favorable with no recurrence at follow-up.

In this paper we extend several classical results on pointed torsion theories – also known as torsion pairs – to the setting of non-pointed torsion theories defined via kernels and cokernels relative to a fixed class of trivial objects (often referred to as pretorsion theories ). Our results are developed in the recently introduced framework of (non-pointed) prenormal categories and other related contexts. Within these settings, we recover some characterisations of torsion and torsion-free subcategories, as well as the classical correspondences between torsion theories and closure operators. We also suitably extend a correspondence between torsion theories and (stable) factorisation systems on the ambient category, known in the homological case. Some of these results are then further specialised to an appropriate notion of hereditary torsion theory. Finally, we apply the developed theory to construct new examples of pretorsion theories.

Objective:To analyze the application experience and operation result of continuous irrigating mode of otoendoscopic surgery in patients with lateral semicircular canal fistula as a complication of cholesteatoma, so as to provide a basis for the feasibility and safety of the operation. Methods:A total of 45 patients diagnosed with middle ear cholesteatoma who underwent transcanal endoscopic surgery in our department between November 2022 and March 2025 were enrolled, among whom 13 presented with labyrinthine fistula. Mastoid opening and lesion removal were performed in continuous irrigating mode, patients with labyrinthine fistula underwent external semicircular canal fistula repair and tympanoplasty were completed at the same time, and outpatient re-examination was performed at 1 week, 3 weeks, 8 weeks and 12 weeks after surgery, of which endoscopic examination was performed at 3 weeks, 8 weeks and 12 weeks after surgery, and pure tone hearing threshold test was performed 6 months after surgery. Thereafter, regular re-examinations will be conducted every 3 to 6 months. The operation time, preoperative and postoperative vertigo symptoms, changes in bone conduction threshold of pure tone auditory threshold, the time of postoperative dry ear and surgical cavity epithelialization were analyzed. Results:A total of 13 patients were collected, all of whom had external semicircular canal fistulas, including 5 males and 8 females, aged 21 to 77 years, with a mean age of （47.62±15.40） years, with lesions located on the left side in 7 cases, 6 cases on the right side, 6 cases of type Ⅰ fistula and 7 cases of type Ⅱ fistula.The average operation time was（164.77±12.77） min, There was no statistically significant difference in the operation time compared with patients without labyrinth fistula（155.13±9.15） minutes（P=0.563）. 11 cases（84.62%） had dry ears 3 weeks after surgery, 9 cases（69.23%） reached cavity epithelialization at 8 weeks after surgery, and all cases reached epithelialization at 12 weeks after surgery. There was no statistically significant difference in the average bone conduction threshold before and after the operation（P=0.064）, and the average air-bone conduction difference was statistically significant（P=0.012）. One patient had vertigo symptoms after surgery, which was relieved 1 week after surgery, and the bone conduction hearing threshold of this patient did not change compared with that before surgery. Conclusion:①Continuous irrigating mode in otoendoscopic surgery provides a clear surgical field and allows for safe lesion removal, with operation times comparable to those in patients without labyrinthine fistula. ②No significant postoperative decline in bone conduction hearing thresholds was observed, while the air-bone gap was significantly improved. ③The low incidence of postoperative vertigo, along with shorter time to dry ear and cavity epithelialization, suggests that transcanal endoscopic surgery with continuous irrigation is a safe and effective approach for managing labyrinthine fistula.

Treatment of complex anal fistulae remains a significant challenge for physicians and patients. A sphincter-preserving technique with bioactive platelet-rich fibrin matrix is one option. This three-year study aimed to evaluate the efficacy of bioactive platelet-rich fibrin matrix in treating complex anal fistulae. This retrospective study analysed data from 2019 to 2022 of patients diagnosed with complex anal fistulae treated with a platelet-rich fibrin matrix at a tertiary centre. Endoanal ultrasound was used to morphologically characterize fistulas using Park's classification. Pearson's chi-squared and Kaplan-Meier (log-rank) analyses were used to evaluate between-group differences. A total of 213 patients were included in the study (181 with cryptoglandular fistulae and 32 with Crohn's disease-associated fistulae) with a median follow-up of 6.6 months (range 0.5-67.1 months). Cavities and secondary tracts were identified in 14.6% and 34.7% of the patients, respectively. External opening closure occurred in 32% after one procedure and 43% cumulatively after a second intervention. Healing rates did not differ statistically by aetiology or fistula location. Cavities and secondary tracts were associated with failure. During follow-up, 23% of the secondary tracts healed, whereas cavities derived no significant benefit from the intervention. No serious complications were reported. Platelet-rich fibrin matrix is a simple and safe sphincter-preserving technique that achieves reasonably good results in the treatment of cryptoglandular and Crohn's disease-associated fistulae. While secondary tracts may respond well, further research is required to optimize the management of fistulae associated with cavities.

The clinical benefits of pulsatile perfusion during cardiopulmonary bypass (CPB) remain a subject of debate. This study aimed to compare clinical outcomes between pulsatile and non-pulsatile perfusion during CPB in patients undergoing elective cardiac surgery. Eighty patients undergoing elective atrial septal defect (ASD) closure or mitral valve replacement (MVR) between July 2019 and July 2020 were randomized to two groups: pulsatile perfusion (PP) group and non-pulsatile perfusion (NP) group. All surgeries were performed by a single surgical team. In the PP group, pulsatile flow was maintained at 60-80 per minute for adults and 80-120 per minute for pediatric patients, pulse pressure was maintained higher than 15mmHg, while all other intraoperative management and perioperative protocols were kept consistent between groups. The two groups were compared in terms of length of ICU stay, hospital stay, renal function test, liver function test, and complications. 77 patients with a mean age of 33.8±15.9 were included in the final analysis. The groups were similar in demographics, clinical and intra-operative variables, except body surface area and baseline creatinine, which were higher in the pulsatile group. Length of ICU stay, hospital stay, liver function tests, renal function tests, and complications were similar across both groups, except for higher urea (p-value 0.049) in the pulsatile group. This study did not demonstrate significant differences in clinical outcomes between pulsatile and non-pulsatile flow during CPB in elective cardiac surgery. Routine use of pulsatile flow cannot be recommended based on current findings. The study was limited by its restriction to patients undergoing ASD closure or MVR surgery and the dominance of younger patients without major comorbidities.

Advanced therapies infrequently achieve complete fistula closure in patients with Crohn's disease (CD). The primary objective of the STOMP2 clinical trial was to determine whether the implantable autologous cell therapy AVB-114 is effective in inducing remission of persistent Crohn's perianal fistulas versus standard of care. Eligible patients had a single perianal fistula tract and had failed previous treatment or had documented medication intolerance to biologic or conventional CD therapy. All enrolled subjects underwent surgical fistula optimization and adipose tissue biopsy collection (to manufacture AVB-114) followed by 1:1 randomization to either standard of care (repeat fistula optimization including seton replacement) or AVB-114 implantation. The primary end point was combined fistula remission at 36 weeks, defined as closure of the external opening, no drainage of fluid despite gentle finger compression, and no collections >2 cm in at least 2 of the 3 dimensions on MRI. Subjects at 14 US sites were equally randomized to SoC (N = 24) or AVB-114 (N = 24). Week 36 combined remission was 8.3% and 45.8% for subjects randomized to SoC and AVB-114, respectively (38% difference, 95% CI 11%-60%; P = 0.0078). At week 36, MRI revealed no subjects with collections >2 cm, radiological improvement (≥50% decrease in the Magnetic Resonance Novel Index for Fistula Imaging in Crohn's Disease (MAGNIFI-CD) score from baseline) in 1 SoC subject and 3 AVB-114 subjects, and radiological healing (complete resolution of T2-weighted hyperintensity in fistula tract) in 2 SoC subjects and 5 AVB-114 subjects. Through week 36, there were 40 and 56 treatment emergent adverse events for SoC and AVB-114, respectively. There were no serious treatment emergent adverse events in the AVB-114 group through week 36. A significantly higher proportion of patients treated with AVB-114 achieved combined remission vs SoC, and the treatment was well tolerated. These data support the safety and efficacy of AVB-114 in persistent Crohn's perianal fistulas.