bluuebunny/crossref_metadata_2025_split huggingface dataset:
1791-PUB: Implementation of a Food Pharmacy into a Pediatric Diabetes Clinic
Authors: FRYMARK EMILY , RICHARDSON ALEXIS M. , KESSENICH HADLEY , HOLLY SARAH L. , ODIMAYOMI OMOTOKE , TOPPING SUSAN , LEON JACQUELINE , MAJIDI SHIDEH 
Published: June 2023

Introduction: Social Determinants of Health (SDOH) is an essential focus in providing equitable diabetes care. Food and nutrition are integral parts of T1D and T2D management. Food insecurity (FI) increases the risk for T2D and is associated with higher A1C levels and hospitalization in those with diabetes. Children’s National Hospital and Capital Area Food Bank (CAFB) collaborated to create a Food Pharmacy within the diabetes clinic.
Methods: The Food Pharmacy Program was implemented October 2021. Groceries, including grains, vegetables, fruit, dairy, and protein, are provided by the CAFB and stored in clinic. Each set of bags weighs about 50 lbs and serves a family of 4 for 3 days. A FI questionnaire is provided to diabetes patient families during their clinic visit. If positive, families qualify to receive supplemental groceries from the clinic, which are provided to families before they leave. Menus change on a quarterly basis based on feedback from patients and the dietetic team.
Results: To date, 62% screened positive for FI. Approximately 20% of our diabetes patient population (496 families) have received groceries (46% male; mean age 14.4±3.9 years; 46% T1D; 51% prediabetes or T2D; mean diabetes duration 3.4 years; Ethnicity: 32% Hispanic; Race: 55% Black; 5% Caucasian). Over the initial 6 months of the program, an average of 49 families per month were receiving groceries. Since then, an average of 117 families per month are receiving groceries. A total of 24,800 pounds of food have been provided through the Food Pharmacy.
Conclusions: A Food Pharmacy was successfully implemented within a diabetes clinic, showing the benefits of a partnership between a hospital and local food bank focusing on SDOH to improve patient care. A research project is being developed to study diabetes, psychosocial, cost analysis, and health utilization outcomes with a more intensive food intervention in youth with prediabetes or T2D.

Disclosure
E. Frymark: None. A.M. Richardson: None. H. Kessenich: None. S.L. Holly: None. O. Odimayomi: None. S. Topping: None. J. Leon: None. S. Majidi: None.
1792-PUB: Predictors of Weight Loss Variability in the COVID-19 Disrupted ACT1ON Diet Pilot in Young Adults with T1D
Authors: IGUDESMAN DARIA , ADDALA ANANTA , CRANDELL JAMIE , MUNTIS FRANKLIN R. , ZAHARIEVA DESSI P. , THOMAS JOAN , CORBIN KAREN , CASU ANNA , SUE KIRKMAN M. , KOSOROK MICHAEL R. , PRATLEY RICHARD E. , MAAHS DAVID M. , MAYER-DAVIS ELIZABETH J. 
Published: June 2023

We reported that young adults with T1D and overweight or obesity lost equivalent weight when randomized to 3 months of a hypocaloric low carb or moderate low fat diet or an ad libitum Mediterranean diet. The remainder of the 9 month study was disrupted by COVID-19. We identified predictors of weight loss variability between study enrollment and completion/dropout, accounting for % of participant study time during COVID-19.
Potential predictors of % weight loss were identified a priori and included in multivariate models when univariate correlations had a p-value &lt;0.2. General linear models used backward elimination. We introduced variables in groups (order: demographic and design, clinical, behavioral); the variable with the highest p-value was sequentially removed until those with p&lt;0.2 remained.
Crude weight changed by -0.87% (95%CI -2.6, 0.85, p=0.31, n=48) over 12 months (IQR 10.8, 12.9). Accounting for % COVID-19 time and study duration, 26.3% (model p=0.07) of weight loss variability was collectively explained by employment status (full-time lost less weight than unemployed), age at highest weight (weight loss decreased with younger age), education level (more weight loss with bachelor degree or higher than less education), and HbA1c (weight loss decreased with higher HbA1c, Table). Larger studies should confirm these findings and uncover additional predictors of weight loss success in T1D.

Disclosure
D.Igudesman: None. M.R.Kosorok: None. R.E.Pratley: Other Relationship; Bayer Inc., Corcept Therapeutics, Dexcom, Inc., Gasherbrum Bio, Inc., Hanmi Pharm. Co., Ltd., Hengrui (USA) Ltd., Merck Sharp & Dohme Corp., Novo Nordisk, Pfizer Inc., Rivus Pharmaceuticals Inc., Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. E.J.Mayer-davis: None. A.Addala: None. J.Crandell: None. F.R.Muntis: None. D.P.Zaharieva: Advisory Panel; Dexcom, Inc., Research Support; Hemsley Charitable Trust, International Society for Pediatric and Adolescent Diabetes, Insulet Corporation, Speaker's Bureau; American Diabetes Association, Ascensia Diabetes Care, Medtronic. J.Thomas: None. K.Corbin: None. A.Casu: None. M.Kirkman: None.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases (1DP3DK113358-01)
1793-PUB: Effects of Nonnutritive Sweeteners on Glycemic Indices in Healthy Persons, with Overweight or Obesity, or Diabetes—A Systematic Review and Meta-analysis of Randomized Controlled Trials
Authors: AMIRHOSSEIN GOLZAN S. , ESPINOSA ALAN , ABBASI MOHAMMADMAHDI , MOVAHEDIAN MINA , FATHI MOBINA , HEKMATDOOST AZITA 
Published: June 2023

Evidence on nonnutritive sweeteners (NNS) and glycemia is controversial due to possible mechanisms promoting glucose intolerance. No study had systematically assessed variations in glycemic outcomes based on NNS type and dose, length of exposure, and nature of the comparator in trials evaluating subjects undergoing different clinical conditions. We conducted a systematic review and meta-analysis summarizing trials contrasting NNS consumers vs. non-consumers to assess the effect on eight glycemic indices. In participants without any major disease at baseline, NNS intake significantly increased fasting blood glucose (FBG). FBG and fasting insulin (FI) were higher among NNS consumers with hyperglycemia, those who followed for &gt; 8wk, consumers of ≤ 350 mg/d, and participants receiving sucralose. Sucralose also increased 2h-glucose and 2h-insulin but reduced HbA1c. Aspartame increased HbA1c. Participants with obesity consuming NNS displayed significantly less FBG, FI, and HOMA. Results were consistent when clustering those with controlled baseline glycemia, subjects followed for ≤ 8wk, consumers of &gt; 350 mg/d, and those replacing sugar with NNS. NNS consumers with baseline hyperglycemia exhibited less FI and HOMA. Participants consuming ≤ 350 mg/d displayed reductions in FBG and HOMA. Trials evaluating stevia consumers reported less FBG and FI levels. We found no overall effect on persons with diabetes. Subgroup assessments revealed that persons with diabetes with uncontrolled glycemia at baseline or who were followed for &gt; 10wk displayed higher FI. In summary, the effect of NNS in glycemia varies across indices and between persons with inequivalent clinical conditions. Higher doses of NNS or longer interventions do not necessarily improve glycemic indices. Better-designed trials evaluating glycemic metabolism are needed to elucidate if NNS can be used as an alternative to sugar.

Disclosure
S.Golzan: None. A.Espinosa: None. M.Abbasi: None. M.Movahedian: None. M.Fathi: None. A.Hekmatdoost: None.
1795-PUB: Teaming Up for T1D with Telehealth—An Initial Look at Youth and Family Coping following a New T1D Diagnosis
Authors: HOWARD KELSEY R. , SMITH NICHOLAS DAVID W. , GARZA KIMBERLY P. , WEISSBERG-BENCHELL JILL , FELDMAN MARISSA 
Published: June 2023

Purpose: A diagnosis of T1D is often associated with increased youth and parental distress as families learn to manage complex daily diabetes tasks and navigate glycemic fluctuations. This study sought to capture the early experiences of families following initial diagnosis, specifically focusing on its psychosocial impact.
Method: Eight children (8-12; M=9.0; SD=1.3), 12 teenagers (13-17; M=14.7; SD=1.9) with T1D and 31 parents of youth ages 3-17 diagnosed with T1D were surveyed two weeks following diagnosis as part of a larger pilot of a prevention intervention to support families during the first-year post diagnosis. Additionally, electronic medical records were reviewed 3 months post diagnosis to evaluate health care utilization and medical outcomes.
Results: Two weeks post T1D diagnosis, some parents (38.7%) and youth (18.8%) reported elevated symptoms of depression. Similarly, 36.7% of parents and 12.5% of youth reported elevated symptoms of anxiety. Fewer youth (11.8%) and parents (11.1%) endorsed elevated diabetes distress at two weeks post-diagnosis. At 3 months, mean A1c was 7.5% (SD = 1.4) and mean time in range was 67% (SD = 21.8). No baseline variables were correlated with A1c at 3 months post-diagnosis; however, youth report of family conflict was negatively correlated with time in range (r = -.761; p &lt;.01). At 3 months following diagnosis, nearly all (92.6%) youth were using CGM, while few (7.7%) were using insulin pumps.
Discussion: This study examined the experiences of youth and their parents following a T1D diagnosis, along with 3-month post diagnosis clinical outcomes. Many parents experience elevated symptoms of depression and anxiety two weeks following diagnosis. Few baseline variables correlated with clinical outcomes at three months following diagnosis. Future studies should examine family experiences in the first year following diagnosis, as well as interventions that promote positive coping among youth and their parents.

Disclosure
K.R.Howard: Stock/Shareholder; Abbott, AbbVie Inc. N.W.Smith: None. K.P.Garza: None. J.Weissberg-benchell: Advisory Panel; Beta Bionics, Inc., Research Support; Beta Bionics, Inc. M.Feldman: None.

Funding
JDRF (2-SRA-2020-985-S-B)
1798-PUB: Clinical Factors Associated with Positive Depression Screen in Youth with Type 1 Diabetes Before and During the COVID 19 Pandemic
Authors: SRIRAM SWETHA , MARCH CHRISTINE , LEIKAM LINDSAY M. , SCHREIBER JUSTIN , MUZUMDAR RADHIKA , LIBMAN INGRID 
Published: June 2023

We have previously shown that 1 out of 5 adolescents with type 1 diabetes (T1D) scored positive for depression with no differences between 2019 (pre pandemic) vs 2020 (pandemic). We aimed to identify clinical factors associated with a positive screen and if these differ pre (2019) and during (2020) the pandemic in a large academic children’s hospital. We included 239 adolescents with T1D who completed a PHQ-9 screen in both years (52% female, 97 % non-Hispanic white, mean (SD) age 15.1 ± 1.7 years, T1D duration 7.0 ± 4.0 years, 54% and 63% were on insulin pumps, 68% and 62% were on continuous glucose monitors in 2019 and 2020 respectively. In 2019 12%, 4% and 3% had mild (PHQ-9 score 5-9), moderate (score 10-14), and severe (score &gt;15) depression respectively with similar rates in 2020 at 9%, 3% and 3%. In univariable logistic regression, elevated HbA1c (OR 1.59, p&lt;0.001) and prior mental health history (OR 15.5, p&lt;0.001) increased the odds of a positive screen in 2019, but not age (p=0.94), diabetes duration (p=0.64) or pump/CGM use (p=0.33/p=0.16). Similar findings were seen in 2020. Proportion of adolescents with a positive 2019 screen who were not in counseling (n=6, 14%) doubled in 2020 (n=10, 29%), possibly reflecting inadequate access to services during the pandemic, albeit small numbers. There was no association between a positive depression screen and screening for comorbidities (thyroid, celiac disease, and dyslipidemia) or complications (nephropathy and retinopathy) in 2019 or 2020. Though the prevalence of depression did not change during the pandemic, the most vulnerable groups were those with pre-existing mental health diagnoses and uncontrolled diabetes. This highlights the need for continued mental health therapy services in this group. Screening for comorbidities or complications was not associated with a positive depression screen which is reassuring and may relate to these screens being done in clinic, including screening for retinopathy.

Disclosure
S.Sriram: None. C.March: None. L.M.Leikam: None. J.Schreiber: None. R.Muzumdar: None. I.Libman: Advisory Panel; Novo Nordisk.
1801-PUB: Efficacy and Safety of Once-Weekly Semaglutide in People with Type 1 Diabetes in Real-World Practice
Authors: BELLIDO VIRGINIA , GROS HERGUIDO NOELIA , AMUEDO SANDRA , BAENA ARIZA LUIS , ALFONSO SOTO M. 
Published: June 2023

Introduction: Semaglutide has shown significant improvements in weight and HbA1c in T2D, but the data about the efficacy and safety in people with T1D (PWT1D) are scarce.
Aims & Methods: We conducted a retrospective study including adults with T1D and obesity who had initiated once weekly (OW) semaglutide adjunct to insulin, to evaluate its efficacy and safety.
Results: Twenty-one subjects were included (52.4% female, mean age 44.2 ± 12.9 years, diabetes duration 19.1 ± 10.8 years, HbA1c 7.7 ± 0.8%, BMI 38.3 ± 5.9 kg/m2). Of them, 47.6% had hypertension, 52.4% dyslipidaemia, 23.8% cardiovascular disease, and 19% renal disease. Mean treatment duration was 30.4 weeks. Mean OW semaglutide dose was 0.8 ± 0.2 mg. Significant reductions in HbA1c (-0,6 ± 0.7%), weight (-8.1 ± 6.1 kg; -7.5 ± 5.8%) and daily insulin dose (-20.7 ± 18.9 U/day) were achieved. An HbA1c reduction of ≥ 0.4% was seen in 61.9% of subjects. Weight loss ≥ 5% and ≥ 10% were achieved in 57.1% and 33.3% of cases, respectively. Significant improvements in time in range (+8.8 ± 13.4%) and time in hyperglycemia &gt;250 mg/dL (-5.3 ± 5.1%) were attained. Four subjects experienced gastrointestinal adverse events, and two of them discontinued treatment.
Conclusions: Adjunct treatment with OW semaglutide in PWT1D in a real-life setting resulted in promising results in glycemic control, weight, and insulin requirements, in a safe and well-tolerated manner.

Disclosure
V.Bellido: None. N.Gros herguido: None. S.Amuedo: None. L.Baena ariza: None. S.M.Alfonso: None.
1802-PUB: Liraglutide as a Potential Drug Repurposing Candidate for Alzheimer’s Disease and Related Dementia—Real-World Evidence
Authors: WANG TIANSHENG , BUSE JOHN B. , PATE VIRGINIA , STÜRMER TIL 
Published: June 2023

Previous studies suggested GLP-1 receptor agonists (GLP1RA) may improve cognitive function and liraglutide’s effect on Alzheimer’s disease is being evaluated by the ELAD (Evaluating Liraglutide in Alzheimer's Disease) clinical trial. To examine whether liraglutide decrease Alzheimer’s disease and related dementia (ADRD) risk compared with other antidiabetics, we implemented an active comparator, new user cohort design identifying initiators of liraglutide, DPP-4 inhibitors (DPP4i), respectively, using a US nationwide 20% random sample of fee-for-service Medicare beneficiaries aged 70+ with parts A, B, and D coverage from 2007-2019. We required patients to have 2nd prescription of the same drug class and be free of ADRD in the 3-year window (during which requiring 3-year continuous enrollment of parts A, B) prior to drug initiation. The ADRD outcome was defined as 1) ≥1 ADRD claims in 1 year AND 2) ≥1 ADRD claims in another year or nursing home stay ≥ 6 months in the 3-year follow-up period. We estimated propensity scores (PS) to balance confounders across cohorts and estimated adjusted risk difference (RD) and 95% CI using inverse probability treatment and censoring weight. The initiators of liraglutide (n=1260) and DPP4i (n=15952) were followed for a median (IQR) duration of 3.0 (2.0 to 3.0) and 3.0 (1.7 to 3.0) years, respectively. During follow-up, incident cases of ADRD was 196 and 3215 in liraglutide and DPP4i, respectively; and incident rate was 63 and 85 per 1000 person-years, respectively. Adjusted RD (%) was -4.4 (95%CI -6.6 to -2.39) comparing liraglutide to DPP4i. Results were consistent across sensitivity analyses with varying exclusion criteria, baseline period, and outcome definitions. Our active comparator, new user cohort study of older patients showed liraglutide is associated with a decreased ADRD risk compared with alternatives. This study is limited by the relatively short duration of treatments.

Disclosure
T.Wang: None. J.B.Buse: Consultant; Alkahest, Anji Pharmaceuticals, AstraZeneca, Bayer Inc., Biomea Fusion, Inc., Boehringer Ingelheim International GmbH, CeQur SA, Cirius Therapeutics, Inc., Corcept Therapeutics, Eli Lilly and Company, GentiBio, Glycadia, Glyscend Inc., Janssen Pharmaceuticals, Inc., Mellitus Health, Pendulum Therapeutics, Praetego, LLC, Stability Health, Terns, Inc, Valo, Other Relationship; Novo Nordisk, Research Support; Dexcom, Inc., Novo Nordisk, vTv Therapeutics, Stock/Shareholder; Glyscend Inc., Mellitus Health, Pendulum Therapeutics, PhaseBio Pharmaceuticals, Inc., Praetego, LLC, Stability Health. V.Pate: None. T.Stürmer: Stock/Shareholder; Novartis, Novo Nordisk, Roche Pharmaceuticals.

Funding
American Diabetes Association (4-22-PDFPM-06 to T.W.)
1804-PUB: Switching from Glucagon-Like Peptide-1 Receptor Agonists Therapy to Second Generation Basal Insulins—Comparative Effectiveness Analysis of Glargine 300 U/mL vs. Degludec 100 U/mL—The RESTORE-G Real-World Study
Authors: CANDIDO RICCARDO , NICOLUCCI ANTONIO , LAROSA MONICA , CHIARA ROSSI MARIA , NAPOLI RAFFAELE ,   RESTORE-G STUDY GROUP
Published: June 2023

ADA recommends early use of GLP1-RA in T2DM. In patients treated with GLP1-RA and needing therapy intensification, the switch to insulin therapy is still a common approach. Compared to first generation basal insulins, second generation ones (2BI) provide similar or improved efficacy with better safety profile. Aim of this RESTORE-G sub-study was to perform a comparative effectiveness analysis of switching to Glargine 300 U/mL (Gla-300) vs. Degludec 100 U/mL (Deg-100) in patients on GLP1-RA therapy (±oral hypoglycemic agents) needing intensification. Table shows sample sizes, patients characteristics and propensity score (PS) adjusted effectiveness results.

Statistically significant larger reductions of HbA1c and FBG were obtained with Gla-300 vs. Deg-100 after 6 months. No statistically significant between-group differences were documented in weight and 2BI dose changes. PS matching (sensitivity analysis) confirmed the larger effect of Gla-300 vs. Deg-100 on HbA1c reduction [estimated mean difference -0.55% (95%CI -1.02;-0.08); p=0.02]. Switch from GLP1-RA to 2BI is a valuable option and Gla-300 vs. Deg-100 is associated with larger HbA1c decrease. There is urgent need to reduce clinical inertia, witnessed by very high HbA1c levels at switch and suboptimal titration of 2BI.

Disclosure
R.Candido: None. A.Nicolucci: Board Member; AstraZeneca, Research Support; Novo Nordisk, Sanofi, Sobi, Shionogi & Co., Ltd., AlfaSigma, Speaker's Bureau; Boehringer Ingelheim and Eli Lilly Alliance. M.Larosa: None. M.Rossi: Research Support; Sanofi, Novo Nordisk, Shionogi & Co., Ltd., AlfaSigma. R.Napoli: Advisory Panel; Sanofi, Eli Lilly and Company, Novo Nordisk, Research Support; Novo Nordisk, AstraZeneca, Speaker's Bureau; Sanofi, Eli Lilly and Company, Novo Nordisk, AstraZeneca, MSD Life Science Foundation. Restore-g study group: n/a.

Funding
Sanofi
1808-PUB: Effective and Durable Stem-Cell-Enabled Therapy of Autoimmune T1DM in Rodents and Dogs Provides the Scientific Basis for the First-in-Human Trial Using I.P. Administered “Neo-Islets,” 3-D Organoids of Allogeneic Islet, and Mesenchymal Stromal Cells—The Omentum Becomes the New Endocrine Pancreas without the Need for Antirejection Drugs
Authors: GOOCH ANNA , WESTENFELDER CHRISTOF 
Published: June 2023

Two initial reports from Clinical Trials with cell-based interventions for the urgently needed therapy of T1DM show: (a) Open, s.c.-placed encapsulation devices containing insulin-producing progenitor cells that require anti-rejection drugs have failed to adequately improve glycemic control. (b) The intraportal administration of stem cell-derived insulin-producing cells, requiring anti-rejection drugs, has shown promising results in 2 or 3 subjects. However, the inability to retrieve these cells and the need for anti-rejection drugs remain a concern. Our approach harnesses the immune-modulating and -isolating, anti-inflammatory, angiogenic, anti-apoptotic and other trophic actions of Mesenchymal Stromal Cells (MSCs). First, we demonstrated that allogeneic Neo-islets (NIs), islet-sized organoids composed of equal numbers of MSCs and culture expanded Islet Cells do, when given i.p., omentally engraft, redifferentiate, re-express all islet hormones and permanently restore euglycemia in auto-immune diabetic NOD mice, i.e., without encapsulation devices or antirejection drugs. The omentum becomes the new endocrine pancreas. Second, i.p. therapy of spontaneously diabetic pet dogs with allogeneic canine NIs significantly improved glycemia and insulin needs (&gt; 3 years), and this without immune response (abstract this meeting). Third, human NIs permanently correct streptozotocin-induced diabetes in NOD/SCID mice. Removal of the omentally-engrafted NIs promptly restores the diabetic state. No long-term complications of the NI therapy have been observed. Based on this body of evidence, a successful Pre-IND meeting with the FDA was held and final Proof-of-Concept studies that are expected to lead IND approval are ongoing.

Disclosure
A.Gooch: Board Member; SymbioCellTech, LLC, Employee; SymbioCellTech, LLC, Stock/Shareholder; SymbioCellTech, LLC. C.Westenfelder: Board Member; SymbioCellTech, LLC., Employee; SymbioCellTech, LLC., Research Support; SymbioCellTech, LLC., Stock/Shareholder; SymbioCellTech, LLC.
1813-PUB: Cardiorenal Effect of Dapagliflozin and Dapagliflozin-Saxagliptin Combination on CD34+ve Hematopoietic Stem Cells (HSCs) and Podocyte Specific Markers in Type 2 Diabetes Subjects
Authors: RAO NANDULA SESHAGIRI , SEN SABYASACHI 
Published: June 2023

Introduction: Effect of Dapagliflozin (Dapa) and Dapagliflozin-Saxagliptin combination (Combo) was examined on peripheral blood derived CD34+ HSCs as a cellular CVD biomarker. Both Dapa (a SGLT2 receptor inhibitor) and Saxagliptin (a DPP4 enzyme inhibitor) are T2DM meds, but the combo has not been evaluated for cardio-renal risk.
Hypothesis: We hypothesized that Dapa will improve the outcomes when compared to placebo and the Combo maybe even more beneficial.
Methods: 15 subjects were enrolled in 16 weeks, double-blind, three-arm, randomized placebo matched trial, with 10mg Dapa + Saxa placebo (n=4), 10 mg Dapa + 5 mg Saxa (n=5) Combo, And Dapa placebo + Saxa placebo (n=6), Placebo groups. T2DM (30-70 yrs) with HbA1c of 7-10%, were included. CD34+ HSC number, migration, mRNA expression along with biochemistry and urine exosomes were measured. Data were collected at wks 0, 8, and 16. For stats, a mixed model regression analysis was used.
Results: Significant HbA1c (p=0.0357) reduction was noted in Combo group vs Dapa alone and Placebo. hsCRP levels (P=0.0317) and IL-6, two important inflammatory molecules, were significantly reduced in both Dapa and Combo vs Placebo. Leptin levels decreased significantly in both Dapa alone (p=0.035) and Combo group (p=0.015), vs Placebo, however the Adiponectin levels were higher in Dapa alone group. EPC migration improved significantly in both Dapa alone (p=0.05) and Combo group (p=0.05) vs Placebo. Interestingly, urine exosome-based podocyte specific protein such as podocalyxin was actually higher in Combo vs Control.
Conclusions: Several parameters showed significant improvement with both Dapa and Combo vs placebo. However, other than glycemic control Combo didn’t offer any further benefit over Dapa alone in terms of HSC and biochemistry. Moreover, the Combo may have deleterious effect on renal podocyte inflammation which needs to be examined in a larger study.

Disclosure
S.Nandula: None. S.Sen: None.