United States

Abstract Title: 
Exploring the Efficacy and Safety of Antidepressant Usage in Pregnancy

Background:
Perinatal depression is common in approximately 20% of pregnant patients in the United States. Various health and safety challenges make it difficult to treat depression in pregnancy because of the likely toxicity and the side effects of the drugs on the fetus. This chapter provides a detailed review of antidepressants prescribed during pregnancy and assesses their efficacy and safety for both the pregnant patient and fetus. The literature emphasized on the case studies published during June 2021 through March 2024. The medications discussed are: Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), and mood stabilizers. 

Methods:
The methodology of this body of work involved conducting a systematic literature review of research articles accessible from Google Scholar and PubMed. Selected research articles for this study were required to meet the following criteria: 1) article discusses the use of antidepressants in pregnancy 2) article possesses a publication date from June 2021 to March 2024 and 3) article assesses antidepressant use during pregnancy in the United States. Out of 146,000 total search results from Google Scholar and 4,910 total search results from PubMed, 16 studies met the final inclusion criteria for this study.

Results:
SSRIs such as sertraline, fluoxetine, and citalopram, exhibit side effects such as respiratory distress, jitteriness, irritability, vomiting, and persistent pulmonary hypotension. However, there are no congenital side effects and the medication is deemed safe to use in pregnancy. 

SNRIs are antidepressants and include drugs such as venlafaxine, duloxetine, and desvenlafaxine. The side effects of this drug class include gestational hypertension which is dose dependent. Although the medication has no congenital side effects, the medication is not safe to use in pregnancy. 

Mood stabilizers include lithium, lamotrigine, valproate. Side effects are predominantely directed towards the pregnant patient and include dizziness, drowsiness, increased thirst, and rash. Congenital side effects of the drug class include dose-dependent cardiovascular malformations such as Ebstein anomaly. This drug can be used in specific cases by continuously monitoring blood levels.

Overall, SSRIs are deemed the first choice and the safest drug class to use to treat perinatal depression in pregnant patients. 

Conclusion:
Our review of recent literature suggests that while there are studies portraying a correlation between antidepressant use during pregnancy and health risks for the pregnant patient and/or fetus, it is difficult to conclude that exposure to antidepressants alone is causing those systemic health issues. Moreover, several studies have pointed out that there is no direct connection between antidepressant use, especially if taken at the lowest effective dose, and congenital malformations or health defects within the pregnant patient. 

The lack of extensive data or small sample size were mentioned as factors as to why some researchers did not find a definitive correlation. Certain antidepressants, such as paroxetine were noted as contraindications during pregnancy and may not be recommended by health care providers. Although different classes of antidepressants demonstrate risks during pregnancy, the benefits often outweigh the risks by choosing medications that have no known teratogenic effects and fewer side effects for both the pregnant patient and fetus. It is vital to treat depression in pregnancy as it is the most common complication in pregnancy and has the greatest risk of development in the second and third trimesters (Gruszczyńska-Sińczak et. al., 2024). By choosing not to take the required antidepressants, the depressed mother may be jeopardizing her own health as well as that of her child. Of the drugs assessed, SSRIs should be used for moderate to severe depression, with sertraline, escitalopram, or citalopram being preferred first (Dama and Van Lieshout, 2024). Comprehensive strategies to address perinatal depression involve increased awareness, early diagnosis, clear guidelines, and effective treatment (Wang et. al., 2023). 

Because pregnant patients are rarely enrolled in clinical trials, safety information of antidepressants is generally limited (Mansour et. al., 2023). Thus, this study demonstrates the need for thorough clinical trials assessing antidepressant use during pregnancy to determine safety guidelines and treatment options for patients dealing with perinatal depression.

AMA Research Challenge 2024 

Exploring the Efficacy and Safety of Antidepressant Usage in Pregnancy

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Abstract Title
Hackensack Meridian School of Medicine Procedural Doula Program
Nicole Acero MD PGY-1, Gwendolyn Glatz MS-3, Madeline Breda MSc MS-4
PI: Dr. Melissa Figueroa MD MPH

Background
Minor gynecologic procedures are increasingly being conducted in the outpatient office setting. Patients’ comfort is crucial for performing a safe procedure. Evidence on the effectiveness of pharmacologic interventions for pain and anxiety control is conflicting and the evidence on the effect of non-pharmacologic interventions is lacking. Research in this area presents a unique opportunity to benefit both patients and students: pre-clinical medical students have limited opportunities for patient interaction, especially during more intimate procedures such as the pelvic exam. The Hackensack Meridian School of Medicine (HMSOM) Procedural Doula Program (PDP) seeks to train and employ medical students as volunteer doulas for office gynecologic procedures with the goal of assessing whether doula support positively affects patients’ experiences of pain, anxiety, and treatment satisfaction. 

Methods
After each patient consents to participation, they will fill out a demographic data survey. They will also be given a survey to assess pre-procedure and post-procedure pain and anxiety when registering for the appointment, and again 10 minutes after the procedure. The survey will include the 100-mm visual analog scale and the Beck Anxiety Inventory. Data will be de-identified and entered into RedCap.
Surveys will be collected from students via Redcap upon commitment to the program prior to initiating doula training and again after 6 months. Surveys will include a self-assessed 5 point Likert scale and will be administered to assess improvement in communication skills, clinical knowledge and skills. 
This research protocol is IRB-approved (Pro2023-0503).
Results
We anticipate that doula support will significantly decrease the pain and anxiety patients experience during in-office gynecologic procedures, as well as improve their overall satisfaction. We also anticipate that this program will improve medical students’ comfort and ability with patient communication and advocacy, as well as increase their clinical knowledge and skills in an area of OBGYN where students historically have limited experience. 

Conclusion
This research project has the potential to offer gynecology patients another source of support in managing anxiety during stressful and uncomfortable procedures. It also offers pre-clinical medical students the opportunity to interact with real life patients, helping them form their communication skills and clinical knowledge foundation, both in service of current gynecology patients as well as their future patients.

HMSOM Procedural Doula Program

Introduction: Meningiomas are benign tumors of the meninges, the tissues surrounding the brain and spinal cord, and are associated with a greater prevalence in females compared to males. These tumors express progesterone and estrogen receptors, suggesting a possible link to female sex hormones. This study aims to investigate the correlation between a history of hormonal contraceptive use in premenopausal women and a subsequent diagnosis of meningioma in women with and without polycystic ovary syndrome using data from the Epic Cosmos database.

Methods: Data from Epic Cosmos was analyzed to identify women who have been diagnosed with meningiomas who were between the ages of 13 and 50 from 1/1/2005 to 12/31/2023, excluding those with a history of hormone replacement therapy. This study population was stratified into those with a polycystic ovary syndrome (PCOS) diagnosis and those who had been prescribed an oral contraceptive pill (OCP). Meningioma incidence rates were calculated for the stratified groups.

Results: 47,351,376 women in the database who met the population criteria were stratified into those who did and did not have a PCOS diagnosis and did and did not have a history of OCP use. A meningioma incidence rate of 0.196% was found for the 621,656 women with a PCOS diagnosis and no history of OCP use, compared to 0.106% for the 247,076 women with a prior PCOS diagnosis and OCP use. This corresponds to a relative risk of meningioma of 0.48 for PCOS patients who were prescribed OCP compared to those who were not (p-value<0.0001). Comparing women without a PCOS diagnosis, a meningioma incidence rate of 0.120% was found for the 42,644,060 women with no OCP use history, compared to 0.082% for the 3,838,584 women with a history of OCP use. This corresponds to a relative risk of meningioma of 0.68 in non-PCOS patients who were prescribed an OCP compared to those who were not (p-value<0.0001).

Conclusion: Premenopausal OCP use, especially in women with PCOS, is potentially correlated with a decreased incidence of subsequent meningioma diagnosis. The decreased meningioma incidence with OCP use in patients with and without PCOS warrants further investigation. This study underscores the potential benefit of optimizing hormonal medication plans and is the first to utilize a national database to examine the correlation between OCP use, PCOS, and meningioma incidence in the United States from 2005-2023.

Incidence of Meningiomas in Women with History of Oral Contraceptive Use and Polycystic Ovary Syndrome Diagnosis

Background: Racial/Ethnic disparities in breastfeeding practices exist despite strong evidence for significant health benefits of breastfeeding for the mother-newborn dyad. Breastfeeding intentions are known to predict breastfeeding practices at hospital discharge and breastfeeding retention in the long-term. Interventions during postpartum hospitalization can help mothers achieve breastfeeding intentions and reduce racial/ethnic gaps in breastfeeding on discharge. This study aims to identify racial/ethnic disparities in meeting intentions to exclusively breastmilk feed (EBMF) on hospital discharge. Methods: This was a retrospective cohort study of mothers who intended to EBMF, and their newborns delivered at term at a single academic medical center during 2022. The primary outcome was EBMF at discharge. Results: Participants included non-Hispanic Black (NHB) (N=96), Hispanic (N=97) and non-Hispanic white (NHW) (N=955) mothers who intended to EBMF. Mothers who identified as NHB (40.6%) or Hispanic (64.9%) were significantly less likely to EBMF compared to NHW (87.5%) mothers (OR=0.14, 95%CI [0.08, 0.23] and OR=0.37, 95%CI [0.22, 0.61], respectively) at newborn hospital discharge. Rurality, insurance type, gravidity, parity, gestational diabetes and birth weight were not associated with breast feeding choice/practices at discharge, but increasing age was associated with an increased likelihood of EBMF (OR=1.07, 95%CI [1.03, 1.11]), as was NICU admission (OR=2.93, 95%CI [1.18, 7.31]). Cesarean birth was associated with decreased likelihood of EBMF (OR=0.57, 95%CI [0.38, 0.85]) Conclusion: Significant racial/ethnic disparities in EBMF at hospital discharge exist among those who intended to EBMF, which are not explained by differences in other examined covariates.

Racial and Ethnic Disparities in Meeting Intentions to Exclusively Breastmilk Feed at Postpartum Hospital Discharge

Background: Preterm birth remains one of the biggest public health challenges with both obstetric and perinatal implications

Objective: Although a prior history of preterm birth (PTB) is a potential risk factor for recurrence in successive pregnancies, little information is available on whether recurrence risk is modified by race/ethnicity, gestational age at birth, PTB subtypes, and interpregnancy intervals (IPI); therefore, we examined whether PTB recurrence risk is modified by these factors.

Methods: A retrospective cohort study of singleton pregnancies in Kaiser Permanente Southern California (2009-2022) was conducted using data extracted from electronic health records (EHR) on the first 2 (n= 82,610) and 3 (n=14,925) pregnancies. Data on preterm labor triage extracted from EHRs by implementing natural language processing were used to define PTB subtypes (spontaneous PTB [sPTB] and iatrogenic PTB [iPTB]). Logistic regression models were used to estimate adjusted odds ratios (aOR) and their 95% confidence Intervals (CI).

Results: A first pregnancy complicated by PTB was associated with a 6-fold increased risk of PTB in the second pregnancy compared with a first uncomplicated pregnancy (23.29% vs. 4.98%, respectively; aOR, 5.60, 95% CI: 5.23-5.99). Stratified by their subtypes, those with a history of sPTB (aOR: 5.32, 95% CI: 4.87, 5.81) and iPTB (aOR: 8.26, 95% CI: 7.18, 9.50) had increased risk for the same respective subtype at their second pregnancy. PTB recurrence risk persisted across race/ethnicity categories and PTB subtypes with the highest risks observed for iPTB. Compared to pregnancies without PTB in the first two pregnancies (4.58%), those with PTB in both pregnancies (40.94%) were associated with significantly increased PTB risk in their third pregnancy (aOR: 14.59, 95% CI: 11.28-18.88). The recurrence of PTB between 1st and 2nd pregnancy was substantially higher for those who delivered at 20-33 weeks of gestation, regardless of PTB subtype. The risks of both sPTB and iPTB recurrence in successive pregnancies were unrelated to the length of IPI. Underweight pregnant patients whose first pregnancy was complicated by sPTB and iPTB had higher odds of PTB subtype-specific recurrence in a subsequent pregnancy. Non-Hispanic Blacks and Asian/Pacific Islanders had a higher recurrence risk in both subtypes of PTB when compared to their non-Hispanic White counterpart.

Conclusion: We observed significant disparities in recurrent PTB by their subtypes and maternal race/ethnicity among a large integrated healthcare system in Southern California. 
Identifying at-risk populations based on PTB subtypes may be particularly important for intervention strategies targeting sPTB.

Risk of Preterm Birth Recurrence in Successive Pregnancies

Background
Ultraviolet (UV) radiation has been shown to contribute to various ocular disorders, including cataract, pterygium, photokeratitis, and cancers of the conjunctiva and eyelids. Some damage, such as to the cornea, can be reversed as the injured cells can be restored. However, tissues of structures such as the lens and retina can suffer irreversible damage. One in six individuals in the United States wears contact lenses (CL), and it is important these individuals receive maximum protection from UV radiation. Few literature reviews have been performed analyzing the recent evidence comparing various CL brands and materials in terms of their UV-blocking properties as well as synthesizing existing research on how UV-blocking CLs can attenuate damage to ocular structures. The aim of this literature review is thus to provide a critical evaluation of the research in evaluating both in vivo and in vitro studies evaluating the protective effects of UV-blocking CLs against UV-induced ocular damage, compare studies that have evaluated UV transmittance of soft CLs, and discuss the implications of this for ocular health. 

Methods
PubMed was the primary database used along with Google Scholar. For all search phrases and terms, the only filter that was applied was “Species – Human.” Inclusion criteria included peer-reviewed articles published at any point that discussed UV protection in CLs, eye diseases from UV radiation, and properties of specific CLs, such as transmittance in both in vivo and in vitro studies. Exclusion criteria included articles not written in English or articles not clinically relevant to human ocular disorders. 

Results
Results indicate that incorporation of UV-blocking monomers into CLs help attenuate UV-induced damage to various structures of the eye, from the corneal epithelium and conjunctiva to the retina. These UV-blocking lenses can increase the time a wearer can be exposed to UV light before toxic ocular dosage is reached and prevent formation of reactive oxygen species, inflammatory cells, and changes in protein abundance. Multiple studies compared the lotrafilcon B CL material (a non-UV-blocking material) with the senofilcon A material (a UV-blocking polymer). 

Conclusion
The conclusions of this literature review are that UV-protecting CLs can significantly protect against UV-induced damage in all structures of the eye. Contact lens wearers and eye specialists should keep these results under consideration.

A Literature Review on the Efficacy of UV Protection in Contact Lenses Against UV-Induced Ocular Diseases

Cataracts are a significant cause of vision loss. Modern treatment of cataracts involve surgical fragmentation, removal, and replacement of the clouded intraocular lens. Femtosecond laser-assisted pretreatment is a recent advancement that is thought to enhance the precision, efficiency, and safety of cataract surgery. In this study, Cumulative Dissipated Energy (CDE) and intraoperative time in cataract surgeries with and without femtosecond laser pretreatment were observed. 700 eyes in 541 patient charts over a 38-day period were included in this retrospective analysis. We conclude that femtosecond laser pretreatment significantly reduces average effective phacoemulsification time (EPT) by 12% and average intraoperative time by 7% as compared to non-femtosecond laser assisted (conventional) cataract surgery, supporting current data on its efficacy.

A Retrospective Analysis of Cumulative Dissipated Energy during Phacoemulsification and Operative Time in Cataract Surgery with and without Femtosecond Laser-Assistance

Background: Type 2 diabetes mellitus (T2DM) remains one of the greatest threats to vision globally. HbA1c is the gold standard biomarker of blood glucose control, but recent studies have begun to explore the role of Glycemic variability (GV) as a complementary metric capable of stratifying patients’ risk of complications independent of HbA1c. Studies have linked greater GV to reduced retinal microvasculature density in type 1 diabetes mellitus (T1DM), potentially a pathophysiological result of increased GV leading to blood vessel damage. However, no studies have examined the effects of GV on the retinal microvasculature in T2DM. Optical coherence tomography angiography (OCTA) has gained acceptance in Ophthalmology to reproducibly quantify the retinal microvasculature. Here, we sought to correlate quantitative retinal OCTA metrics to GV. 
Methods: Cohort study of adult patients with T2DM. We used the publicly available AI READI dataset, which as of July 2024 includes 204 T2DM patients across three data collection sites and contains clinical characteristics, retinal OCTA imaging (Maestro2, Topcon, Tokyo, Japan), and continuous glucose monitoring (CGM; Dexcom G6, Dexcom, San Diego, USA), among other data. OCTA metrics (vessel area density (VAD) and vessel length density (VLD)) were calculated for the superficial (SCP) and deep (DCP) capillary plexuses of each eye of each patient, and patients with VAD or VLD less than 10% or 10mm^-1, respectively, were excluded for low image quality. The coefficient of variation (CoV) of CGM-measured plasma blood glucose recorded every 5 minutes over 10 days was calculated. Patients with a CoV greater than 0.15 for a particular metric were classified as high variation for that metric, and the remainder as low variation. Difference in mean values between high variation and low variation groups were examined for each OCTA metric (unpaired t-tests). Pearson correlation coefficients were calculated for each calculated OCTA metric and the CoV of CGM-measured blood glucose. 
Results: 198 patients were identified with available imaging. Of these 24 were excluded for poor image quality. A statistically significant difference in VAD between high and low-variation patients was identified, with those with higher variability having lower VAD (p<0.05).
Conclusion: This study extends prior results finding a correlation between higher blood glucose variability and lower retinal microvascular density from T1DM to T2DM. Blood glucose variability may play a significant role in the pathophysiology of microvascular disease in diabetes.

Analysis of Retinal Vascular Changes in Type 2 Diabetes Mellitus Patients Using the AI READI Database

Background: Exudative age-related macular degeneration (eAMD) is a retinal disorder that may result in rapid deterioration of central vision. Tests leveraging artificial intelligence (AI) hold the promise of automatically identifying and categorizing pathological features, enabling the timely diagnosis and treatment of eAMD. This Cochrane systematic review and meta-analysis aim to determine the diagnostic accuracy of AI as a triaging tool for eAMD.

Methods: We searched CENTRAL, MEDLINE, Embase, three clinical trial registries, and DANS for the grey literature up to April 2024. We included studies that compared the test performance of algorithms with that of human readers in detecting eAMD on retinal images. Review authors worked in pairs to independently extract data and assess study quality using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool with revised signaling questions. Assuming a common positivity threshold applied by the included studies, we chose random effects bivariate logistic models to estimate summary
sensitivity and specificity as the primary performance metrics.

Results: We identified 36 eligible studies that reported 40 sets of algorithm performance data, encompassing over 16,000 participants and 62,000 images. We included 28 studies (78%) reporting 31 algorithms with usable performance data in the meta-analysis. The included algorithms used retinal image types as input, such as optical coherence tomography images (N=15), fundus images (N=6), and multi-modal imaging (N=7). The predominant core method used was deep neural networks. Only three of the included 40 algorithms were externally validated; the summary sensitivity and specificity were 0.94 (95% CI 0.90 to 0.97) and 0.99 (95% CI 0.76 to 1.00), respectively, when compared to human graders. All three studies had high risk of bias mainly due to potential selection bias from either
a two-gate design or the inappropriate exclusion of potentially eligible retinal images. Twenty-eight algorithms were reportedly either internally validated or tested on a development set. The pooled sensitivity and specificity were 0.93 (95% CI 0.89 to 0.96) and 0.96 (95% CI 0.94 to 0.98), respectively, when compared to human graders. We did not identify significant sources of heterogeneity
among these 28 algorithms.

Conclusion: Low to very low certainty evidence suggests that an algorithm-based test may correctly identify most individuals with eAMD without increasing unnecessary referrals (false positives) in either the primary or the specialty care settings. Limited quality and quantity of externally validated algorithms highlight the need for high-certainty evidence, which will require a standardized definition for the eAMD on different imaging modalities and external validation of the algorithm to assess generalizability.

Artificial intelligence for diagnosing exudative age-related macular degeneration: findings from a Cochrane Diagnostic Test Accuracy Review

Background
The corneal dystrophies are a group of inherited disorders that are typically bilateral, symmetric, and slowly progressive, unaffected by environmental or systemic factors. Four types of corneal endothelial dystrophies, primarily affecting corneal endothelial cells, have been described. Here, we present a novel corneal endothelial dystrophy characterized by peripheral posterior corneal macular opacities and endothelial dysfunction without stromal opacity. Symptomatic individuals develop corneal edema, with successful restoration of vision achieved through endothelial keratoplasty (EK).

Methods
Thirty-five individuals from seven families, including 13 affected individuals exhibiting peripheral posterior corneal macular opacities, endothelial guttae and corneal edema, and 22 unaffected family members were included in this retrospective case series. Whole-exome sequencing was performed in three families and Sanger sequencing of CHST6 was performed in all individuals. Histological examination of Descemet membrane (DM) excised at the time of EK was performed for three probands. Serum keratan sulfate (KS) levels were measured in members of six families. Functional analysis of identified mutations was performed using CHST6 promoter containing CHST6 expression vector in human keratocytes (HK) and corneal endothelial cells (HCEnC).

Results
None of the affected individuals demonstrated a single corneal stromal deposit, either on slit lamp exam or on anterior segment OCT imaging, excluding the diagnosis of Macular Corneal Dystrophy. Five affected individuals from four families underwent EK, with resolution of the corneal edema. CHST6 sequencing revealed a non-coding promoter mutation (c.-690G>C) in all families, either in homozygous state in five affected individuals from three families or in a compound heterozygous state with a coding mutation (p.R211Q, p.Y268C or p.P280L) in seven affected individuals from the other four families. In silico analysis predicted c.-690G>C to be a regulatory variant, located at the RNA polymerase II binding site. Functional analysis demonstrated that c.-690G>C leads to increased KS sulfation in HCEnC with no change of KS sulfation in HK, while coding mutations p.P280L and p.Y268C resulted in decreased KS sulfation in HK and no change of KS sulfation in HCEnC. DM staining revealed elevated levels of sulfated and non-sulfated KS in DM and endothelium in affected probands. Minimum changes in serum sulfated KS levels were observed in affected individuals.

Conclusion
A novel corneal endothelial dystrophy characterized by peripheral posterior corneal macular opacities and endothelial dysfunction without stromal opacities is associated with promoter mutation c.-690G>C in CHST6 gene. We suggest the name Peripheral Macular Endothelial Dystrophy (PMED) to describe this dystrophy that can be and should be managed with EK.


Characterization of a Novel Corneal Dystrophy - Peripheral Macular Endothelial Dystrophy

Background 
Endophthalmitis is a serious ophthalmic inflammatory pathology that can result in blindness. Intravitreal (IVT) injections, commonly used treatment vectors for various retinal diseases, have been associated with the risk of developing endophthalmitis. This study aims to compare the incidence of endophthalmitis following IVT dexamethasone (Ozurdex) and anti-VEGF injections administered by several vitreoretinal specialists in outpatient settings. 

Methods 
We retrospectively reviewed IVT dexamethasone and anti-VEGF injections conducted by a network of vitreoretinal specialists in outpatient settings between January 2019 and January 2024. Data was collected on the incidence of endophthalmitis within two weeks following ocular injections. The total sample size included 330,572 cases: 318,618 anti-VEGF injections and 11,954 IVT dexamethasone injections. Statistical analysis was performed to compare the observed and expected frequencies of endophthalmitis for each treatment group, and the significance was determined using a p-value threshold. 

Results 
The incidence of endophthalmitis following Ozurdex injection was found to be higher compared to anti-VEGF injections. Specifically, 15 cases of endophthalmitis were reported out of 11,954 IVT dexamethasone injections, resulting in an incidence rate of 0.109%. In contrast, 106 cases of endophthalmitis were reported out of 318,618 anti-VEGF injections, yielding an incidence rate of 0.033%. The observed frequency of endophthalmitis for IVT dexamethasone was significantly higher than the expected frequency (0.125% vs. 0.037%), whereas the observed frequency for anti-VEGF injections was lower than the expected frequency (0.033% vs. 0.037%). The difference was statistically significant, P < .0001, indicating that IVT dexamethasone is more likely than anti-VEGF to cause endophthalmitis. 

Conclusion 
The findings of this study suggest that patients receiving IVT dexamethasone injections are at a higher risk of developing endophthalmitis compared to those receiving anti-VEGF injections. This significant difference in incidence rates highlights the need for clinicians to carefully consider the risks and benefits when choosing between these treatment options. Further research is warranted to explore the underlying factors contributing to the increased risk associated with IVT dexamethasone and to develop strategies for minimizing this risk.

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