bluuebunny/crossref_metadata_2025_split huggingface dataset:
Does Stewardship Still Have A Role?
Authors: Miller Anthony D. , Oldroyd David 
Published: June 2018

ABSTRACT
The paper analyzes the decision of the FASB and IASB not to treat the motivational and control aspects of stewardship as a separate and distinct reporting objective to that of facilitating investment decisions. It does so first by considering the demand for information to control agents, and second by assessing the capacity of decision-useful information to replicate stewardship effects. The paper finds an essence to accounting based on the legal protection of property rights, encompassing stewardship, which has remained constant since earliest times. The decision taken by the boards on stewardship also appears disconnected from changes in the capital markets, as well as the writings on reporting objectives that preceded it.
Opioid Receptor Blockade with Intranasal Naloxone Prevents the Development of Hypoglycemia-Associated Autonomic Failure
Authors: ALEKSIC SANDRA , LONTCHI-YIMAGOU ERIC , HULKOWER RAPHAEL , CAREY MICHELLE , UDE MERCY , MITCHELL WILLIAM G. , SANDU OANA , TOMUTA NORICA , SHAMOON HARRY , HAWKINS MEREDITH 
Published: June 2018

Attainment of near-normal glycemic goals in type 1 diabetes (T1D) is limited by iatrogenic hypoglycemia. Repeated episodes of hypoglycemia lead to Hypoglycemia-Associated Autonomic Failure (HAAF), with blunted counter-regulatory hormone responses. We previously reported that pharmacologic activation of opioid receptors experimentally recapitulates some features of HAAF (Diabetes 66:2764; 2017), and opioid antagonism with intravenous naloxone prevents experimentally induced HAAF in healthy subjects. We therefore hypothesized that intranasal naloxone would augment central blockade of opioid receptors by bypassing the blood-brain barrier, and would provide a feasible outpatient approach to prevent HAAF.
Using a randomized, double-blinded placebo-controlled study design, 7 healthy subjects (7M; age 43±3 year; BMI 25.9±0.9 kg/m2) participated in paired two-day studies, 5 weeks apart. Day 1 consisted of two 120 minute hypoglycemic (∼54 mg/dl) hyperinsulinemic clamps, with hourly intranasal administration of either saline (placebo) or naloxone (4 mg hourly). On day 2, subjects underwent one 120 minute hypoglycemic clamp (∼54 mg/dl). As expected, HAAF was experimentally induced in the placebo studies, based on lower peak epinephrine levels (mean±SEM: first hypoglycemic episode=1375±182 vs. third episode=858±235, pg/ml, p=0.004). With intranasal naloxone, epinephrine levels did not differ from the first to the third hypoglycemic episode (first=942±190 vs. third episode=857±134 pg/ml, p=0.4). Naloxone did not alter the responses of plasma glucagon, cortisol or growth hormone, or hypoglycemic symptoms.
These findings suggest that HAAF can be prevented by acute blockade of opioid receptors during hypoglycemia, presumably by inhibiting opioid receptor activation by circulating endorphins. Thus, acute self-administration of intranasal naloxone could be an effective and feasible ’real-world’ approach to ameliorate HAAF in T1D.

Disclosure
S. Aleksic: None. E. Lontchi-Yimagou: None. R. Hulkower: None. M. Carey: None. M. Ude: None. W.G. Mitchell: None. O. Sandu: None. N. Tomuta: None. H. Shamoon: None. M. Hawkins: None.
Better Postprandial Glucose (PPG) Control with BioChaperone Combo (BC Combo) than with Lispro Mix25 (LMx) or Separate Glargine and Lispro (G+L) Administrations in Subjects with Type 2 Diabetes (T2DM)
Authors: HEISE TIM , MOERSCHEL LEONA PLUM , MÉGRET CLAIRE , HERBRAND THERESA , VACHER VÉRONIQUE , ANASTASSIADIS ERNESTOS , KLEIN OLIVER , GAUDIER MARTIN , SOULA OLIVIER , GLEZER STANISLAV , ALLUIS BERTRAND , MEIFFREN GRÉGORY 
Published: June 2018

BC Combo is a co-formulation of prandial insulin lispro (25%) and basal insulin glargine (75%) with a rapid “prandial“ insulin component and prolonged flat “basal“ component compared to LMx. In this study the effects of BC Combo on PPG vs. LMx and G+L were investigated. Thirty-nine T2DM subjects (mean±SD age 60.8±7.5 years and HbA1c 7.97±0.6%) were randomized to receive the three insulin combinations immediately before a standardized solid meal test (MMT, 20% protein 30% fat 50% carbohydrates) in a double-blind, double-dummy, cross-over design. The individual insulin dose was the same for each visit day (mean 0.62 U/kg). BC Combo demonstrated improved PPG compared to LMx (Figure, reduction ∆AUCBG,0-2h of 18%, p=0.0009) and G+L (reduction ∆AUCBG,0-2h of 10%, p=0.0450). The proportion of subjects experiencing documented symptomatic hypoglycemic events (plasma glucose &lt;70 mg/mL) over 24h was numerically lower with BC Combo (15.8%) vs. LMx (32.4%) and G+L (21.6%). The total insulin PK profile of BC Combo showed a faster time to insulin peak and a lower exposure in the late prandial phase (2-6 h) than LMx and G+L.
In conclusion, BC Combo demonstrated superior PPG control in T2DM subjects with numerically fewer subjects experiencing symptomatic hypoglycemia compared to both LMx and separate G+L.

Disclosure
T. Heise: Research Support; Self; ADOCIA, Boehringer Ingelheim GmbH, Dance Biopharm, Eli Lilly and Company, Janssen Research & Development, MedImmune, Merck Sharp & Dohme Corp., Mylan, Nordic Bioscience, Novo Nordisk A/S, Poxel SA, Roche Diagnostics Corporation, Saniona, Sanofi, Senseonics, Zealand Pharma A/S. Advisory Panel; Self; Novo Nordisk A/S, Mylan. Speaker's Bureau; Self; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk A/S, Sanofi. L. Plum-Moerschel: None. C. Mégret: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. T. Herbrand: None. V. Vacher: Employee; Self; ADOCIA. E. Anastassiadis: None. O. Klein: None. M. Gaudier: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. O. Soula: Board Member; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. Employee; Spouse/Partner; ADOCIA. S. Glezer: Stock/Shareholder; Self; Sanofi. Stock/Shareholder; Spouse/Partner; Sanofi. Employee; Self; ADOCIA, Novo Nordisk Inc.. Employee; Spouse/Partner; Pfizer Inc., Teva Pharmaceutical Industries Ltd.. Stock/Shareholder; Spouse/Partner; Teva Pharmaceutical Industries Ltd.. B. Alluis: None. G. Meiffren: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA.
Follow-On Basal Insulin—Can Online CME Improve Clinical Knowledge and Ability to Use Effectively?
Authors: LARKIN AMY , DROPKIN JESS , LE ANNE 
Published: June 2018

We assessed baseline knowledge of follow-on basal insulin and if an online, video-based, continuing medical education (CME) roundtable activity could improve the clinical knowledge and competence of primary care physicians (PCPs) and diabetologists/endocrinologists (D/Es) regarding follow-on basal insulin. A 3-question knowledge/competence and 1-question confidence linked pre-/post-assessment study design with McNemar’s chi-squared test (5% significance level, P &lt;.05) and Cramer’s V (&lt;0.no effect; 0.06-0.15 small effect; 0.16-0.30 medium effect; &gt;0.30 large effect) assessed educational effect. The activity launched February 14, 2017, and data collected through March 20, 2017. PCPs (N=284) demonstrated a lower baseline knowledge level compared to D/Es (N=57): 9% of PCPs compared to 23% of D/Es correctly identified PK/PD data for follow-on insulin glargine 14% of PCPs compared to 30% of D/Es correctly identified a patient for whom follow-on basal insulin was a good therapeutic option Overall improvements were seen after participation in for both PCPs (n = 284; large effect of V= 0.329) and D/Es (n = 57; medium effect of V= 0.217). Improvements include: 56% more PCPs (P&lt;.001) and 38% more D/Es (P&lt;.001) accurately selected a patient for follow-on basal insulin use 30% more PCPs (P&lt;.001) and 16% more D/Es (P=.082) correctly identified PK/PD data for follow-on insulin glargine 12% more PCPs (P=.001) and 10% more D/Es (P=.123) selected an effective strategy for overcoming a common barrier to insulin therapy 61% of PCPs and 37% of D/Es reported increased confidence switching patients with T2D from insulin glargine to follow-on insulin glargine This study demonstrates the success of online, video-based roundtable-style CME on improving clinical knowledge and competence of PCPs and D/Es related to follow-on basal insulin. As expected, PCPs had lower baseline knowledge compared to D/Es, and may need more foundational education related to newer therapeutic options for T2D.

Disclosure
A. Larkin: None. J. Dropkin: None. A. Le: None.
Human Regular U-500 Insulin via Continuous Subcutaneous Insulin Infusion vs. Multiple Daily Injections in Adults with T2D—The VIVID Study, Primary Population
Authors: GRUNBERGER GEORGE , BHARGAVA ANUJ , LY TRANG T. , ZISSER HOWARD , ILAG LIZA , MALONE JAMES K. , ZHANG SHUYU , JOHNSON JENNAL 
Published: June 2018

VIVID is the first prospective, randomized controlled trial to assess efficacy and safety of U-500R (Humulin® R U-500) administered by CSII (using an investigational Omnipod U-500™ Insulin Management System) vs. MDI (TID). This 26-week, open-label, multicenter, parallel study (NCT02561078) enrolled adults with T2D on 201-600 units of insulin/day with or without other antihyperglycemic agents. We report data for the primary population (N=340), excluding participants on concomitant GLP-1 RAs or SGLT2 inhibitors. Data for the all-randomized population are reported separately. Baseline characteristics were similar between arms. CSII showed noninferior A1C reduction vs. MDI (primary objective) and superior FPG reduction at 26 weeks with adjustment for multiplicity. CSII showed significantly greater A1C reduction at a lower total daily dose with no multiplicity adjustment. Clinically important hypoglycemia rates (&lt;54 mg/dL) and weight gain were similar; severe and nocturnal (≤70 mg/dL) hypoglycemia rates were statistically higher for CSII vs. MDI (Table). In this population, U-500R via CSII had greater efficacy at a lower dose vs. MDI with higher hypoglycemia rates for some categories. CSII with U-500R may be a viable option for T2D patients on high-dose insulin. Individualized dose titration will be important to safely achieve A1C targets.

Disclosure
G. Grunberger: Research Support; Self; Medtronic MiniMed, Inc., Novo Nordisk Inc.. Speaker's Bureau; Self; Eli Lilly and Company, Novo Nordisk Inc., Sanofi, Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca, Janssen Pharmaceuticals, Inc.. A. Bhargava: None. T.T. Ly: Employee; Self; Insulet Corporation. H. Zisser: Employee; Self; Verily Life Sciences LLC.. Stock/Shareholder; Self; Verily Life Sciences LLC. L. Ilag: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. J.K. Malone: Employee; Self; Eli Lilly and Company. S. Zhang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. J. Johnson: Employee; Self; Eli Lilly and Company.
Is It Possible to Predict the Onset of Nocturnal Severe Asymptomatic Hypoglycemia Using CGM Data of Previous Day and Next Morning in Type 1 Diabetic Patients Receiving Insulin Degludec?
Authors: TAKAHASHI HIROSHI , NISHIMURA RIMEI , UTSUNOMIYA KAZUNORI 
Published: June 2018

The aim of this study to investigate whether the occurrence of nocturnal severe asymptomatic hypoglycemia (NH) may be predicted based on glycemic variability on the previous day and next morning on the day of onset. This study examined patients with type 1 diabetes (T1D) who underwent CGM assessments and received basal bolus therapy of insulin degludec (IDeg) in outpatient setting. NH was defined as glucose levels &lt; 54 mg/dL detected between 12:00 and 6:00 AM. The subjects were evaluated for fasting glucose level, the range of post-breakfast glucose elevation, and glucose level at bedtime (12:00 AM) on the previous day. For comparison, the patients were divided into those with NH and those without by using t-test. Optimal cut-off values for the relevant parameters were determined in order to predict NH using ROC analysis. Thirty-one patients (mean HbA1c values, 7.8 ± 0.7 %) were selected for analysis. NH occurred in 8 patients (26%). Fasting glucose level was significantly lower in those with NH than in those without (61 ± 13 mg/dL vs. 130 ± 68 mg/dL; P = 0.001). The range of post-breakfast glucose elevation was significantly greater in those with NH. Again, the glucose level at bedtime was significantly lower in those with NH than in those without (88 ± 44 mg/dL vs. 144 ± 69 mg/dL; P = 0.044). The cut-off values for predicting NH determined for the relevant factors were as follows: fasting glucose level &lt; 69 mg/dL (sensitivity 0.83/ specificity 0.75/ AUC 0.86, P = 0.003) and bedtime glucose level &lt; 90 mg/dL (0.83/ 0.75/ 0.79, P = 0.017). The results suggest that fasting glucose level of &lt; 69 mg/dL and bedtime glucose level &lt; 90 mg/dL had approximately 80% probability of predicting the occurrence of NH in T1D receiving IDeg. While the post-breakfast glucose levels and the pre- and post-dinner glucose levels were not significantly different, the range of post-breakfast glucose increase was greater in those with NH than in those without.

Disclosure
H. Takahashi: None. R. Nishimura: Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Astellas Pharma US, Inc., Eli Lilly and Company, Abbott, Medtronic, MSD K.K., Novo Nordisk A/S, Sanofi, Takeda Development Center Asia, Pte. Ltd., Kissei Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd.. K. Utsunomiya: None.
BioChaperone 222 (BC222), the New Excipient Enabling the Ultra-rapid BioChaperone Lispro (BCLIS) Formulation, Is Completely Absorbed and Rapidly Excreted after Subcutaneous (s.c.) Injection
Authors: MEIFFREN GRÉGORY , PLUM-MOERSCHEL LEONA , RANSON AYMERIC , ANASTASSIADIS ERNESTOS , SEROUSSI CYRIL , CORREIA JOSÉ , ANDERSEN GRIT , GAUDIER MARTIN , SOULA OLIVIER , GLEZER STANISLAV , ALLUIS BERTRAND 
Published: June 2018

BC222 is an oligosaccharide grafted with anionic charges and amino acid moieties designed to speed up the absorption of insulin lispro in the BCLIS formulation. Non-clinical data indicated that BC222 is rapidly excreted unchanged by the kidney. This open label clinical trial conducted in 12 healthy volunteers [mean±SD age 31.4±9.5 years; weight 95.3±16.8 kg; BMI 28.6±4.1 kg/m²] investigated the PK properties and safety and tolerability of a single s.c. dose of BC222 (equal to the BC222 content in 1.0 U/kg BCLIS) using validated liquid chromatography mass spectrometry assays for BC222 in plasma and urine samples. BC222 was rapidly absorbed, with a median plasma Tmax of 1.2 h (Figure). BC222 was rapidly cleared from the blood with a mean terminal half-life of 2.07 (±0.52) h reaching baseline levels 10-12 h after administration. Urinary BC222 concentrations reached 95.4±4.5% of the injected dose within 12 h post-dosing and was as high as 9 % ± 5% of the total dose after 48h indicating that BC222 was completely absorbed from the s.c. tissue into the blood and quickly cleared via the urine. BC222 was well tolerated and safe with only two mild adverse events occurring in the whole study.
In conclusion, BC222 is completely absorbed after s.c. injection and rapidly excreted by the kidneys.

Disclosure
G. Meiffren: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. L. Plum-Moerschel: None. A. Ranson: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. E. Anastassiadis: None. C. Seroussi: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. J. Correia: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. G. Andersen: None. M. Gaudier: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. O. Soula: Board Member; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. Employee; Spouse/Partner; ADOCIA. S. Glezer: Stock/Shareholder; Self; Sanofi. Stock/Shareholder; Spouse/Partner; Sanofi. Employee; Self; ADOCIA, Novo Nordisk Inc.. Employee; Spouse/Partner; Pfizer Inc., Teva Pharmaceutical Industries Ltd.. Stock/Shareholder; Spouse/Partner; Teva Pharmaceutical Industries Ltd.. B. Alluis: None.
Short-Term Effects of Basal-Plus Insulin Therapy on Early Remission of Newly Diagnosed Type 2 Diabetes
Authors: WOKS EMMA , ETOGA MARTINE CLAUDE ETOA NDZIE , NAMBA RAICHA , KATTE JEAN CLAUDE NJABOU , MBANYA JEAN CLAUDE , SOBNGWI EUGÈNE 
Published: June 2018

Objective: Ketosis prone diabetes has been associated with prolonged normoglycemic remission after discontinuation of early intensive insulin therapy. However, it is unknown if such an approach can produce similar results in classical type 2 diabetes (T2DM). Therefore, our study sought to assess the effects of an outpatient regimen of basal-plus insulin therapy on early remission of newly diagnosed T2DM.
Research Methods: Newly diagnosed T2DM patients had an 8-week course of basal-plus insulin therapy which was then discontinued. Weekly 4-point glycemic profiles were done. HbA1c, lipid profile and insulin sensitivity, using the hyperinsulinemic euglycemic clamp were assessed at baseline and after the intervention. Early remission was defined as HbA1c &lt; 48mmol / mol without treatment for at least 12 weeks
Results: Eleven patients were included on diagnosis. Fasting blood glucose decreased (12.7 [7.8-15.0] vs. 4.9 [4.2-6.2] mmol / l). HbA1c dropped from 101.0 [84.0 -108.0] to 42.0 [36.0-50.0] mmol / mol, after basal-plus insulin therapy and was maintained at 38.0 [33.0-43.0] mmol / mol after 12 weeks with no active treatment. Ten out of eleven subjects experienced early remission. Insulin sensitivity improved significantly after the intervention with a variation in the adjusted M-value from 7.95 [6.39-11.03] to 12.85 [10.24-14.92] mg / kg / min,. The distinctive feature of those who did not require antidiabetic medications was that their initial standardized M-value was &gt; 5.0 mg / kg / min. A significant decrease in total cholesterol and LDLc was observed from 5.40 [5.17-5.87] to 4.45 [3.57-5.48] mmol / L, and 3.83 [2.82-4.37] to 1.[0.54-2.95] mmol / L, respectively. HDLc increased significantly from 1.14 [1.03-1.40] to 2.12 [1.86-2.69] mmol / L.
Conclusion: Basal-plus insulin therapy is effective, feasible, and safe in newly diagnosed T2DM and can induce early remission as observed in ketosis prone diabetes.

Disclosure
E. Woks: None. M. Etoa ndzie Etoga: None. R. Namba: None. J. Njabou Katte: None. J. Mbanya: Advisory Panel; Self; GlaxoSmithKline plc.. Speaker's Bureau; Self; Novo Nordisk A/S, Sanofi, Servier. E. Sobngwi: None.
The Influencing Factors of Continuous Subcutaneous Insulin Infusion in Newly Diagnosed T2DM Patients
Authors: KE WEIJIAN , LIU LIEHUA , LI YANBING 
Published: June 2018

In order to investigate the influencing factors of continuous subcutaneous insulin infusion (CSII) of 48 newly diagnosed T2DM patients without hypoglycemic agents were analyzed. The enrolled patients were 46.1±9.1 years in age, with a BMI of 25.2±2.8 kg/m2, FPG of 11.6±3.2mmol/L, PPG of 17.4±6.5mmol/L, and HbA1c of 10.8±2.1%. Glucose levels and beta cell function were measured at baseline. An intravenous glucose tolerance test (IVGTT) using 25g of glucose (50ml of 50% glucose) was conducted to assess acute insulin response (AIR) as beta cell function. Serum insulin levels before and 1, 2, 4, 6, and 10 min after glucose injection were measured, and AIR was calculated as the incremental trapezoidal area. The initial insulin dosages of CSII were 0.5-0.7IU/kg according to clinical experience. The insulin dosages were adjusted to achieve euglycemia which was defined as fasting glucose between 4.4 and 6.0 mmol/L and postprandial glucose between 4.4 and 8.0mmol/L as capillary blood glucose values were measured including fasting, premeal and postprandial. CSII therapies were maintained for 14 days and fasting C peptide was measured at 7th day after achieving glycemic targets. The patients achieved glycemic control in 3(3) days. Baseline FPG, PPG, HbA1c, and HOMA-IR were positive related to the days spent to euglycemia (r=0.402, p=0.0and r=0.334, p=0.029 and r=0.352, p=0.015, and r=0.306, p=0.035, respectively). AIR was negative related (r=-0.457, p=0.001). The initial insulin dosages were not associated with the days of achieving glycemic control. The incidents of hypoglycemia of all patients were 3(3) times, which were negative related to C peptide level at 7th day after achieving euglycemia (r=-0.333, p=0.021).
In conclusion, the patients with lower baseline glucose levels and better beta cell function were preferred to achieve glycemic control in shorter time during IIT. The suppression of endogenous insulin secretion was associated with exposure of hypoglycemia.

Disclosure
W. Ke: None. L. Liu: None. Y. Li: None.
Effect of Leptin Replacement Therapy (LRT) on Survival and Disease Progression in Generalized and Partial Lipodystrophy (GL, PL)
Authors: ALI OMER A. , COOK KEZIAH , GUPTA DEEPSHEKHAR , HOLMQVIST DAN , LEE DON , NG COURTNEY K. , BRADT PAMELA , BROWN REBECCA 
Published: June 2018

Lipodystrophy (LD) is an ultra-rare disease associated with significant morbidity and mortality. Effects of LRT on metabolic disease in GL and PL have been studied; but effects on mortality are unknown. We investigated these effects using data from GL and PL patients treated with LRT at NIH (N=114) and cared for but not treated with LRT at 3 centers in the U.S. and Turkey (N=178).
Four abnormalities (liver, kidney, heart, and HbA1c ≥6.5%) were considered. LRT patients had a mean of 2.8 abnormalities prior to treatment, while the mean for untreated patients was 0.7 at a similar age. We used a matching approach to create comparable samples of treated and untreated patients. Each treated patient was matched (using Mahalanobis distance) to an untreated patient to balance across age, gender, type of LD, and number of abnormalities. LRT treatment effect was examined via Cox proportional hazards models of 1) mortality and 2) development of subsequent abnormalities. Additionally, the relationship between abnormalities and mortality was studied in the sample of untreated patients.
Results: A Cox proportional hazards model relating treatment to mortality yielded a hazard ratio (HR) for LRT of 0.34 (p=0.047), meaning that LRT was associated with a 66% decrease in mortality risk. Adjusting for covariates including gender, type of LD, and type of abnormality resulted in a larger decrease in mortality risk (HR 0.21, p&lt;.01).
One possible mechanism for the effect of LRT on mortality is its role in mitigating or resolving abnormalities. A time-varying Cox proportional hazards model relating number of abnormalities present (0 to 4) to mortality among untreated patients found a positive relationship between additional abnormalities and mortality (HR 3.2, p&lt;.01). Separately, we found that LRT reduced the likelihood of developing a third (HR 0.47, p&lt;.01) or fourth abnormality (HR 0.46, p&lt;.05).
In conclusion, these are the first data suggesting that LRT reduces mortality in LD.

Disclosure
O.A. Ali: Consultant; Self; Aegerion Pharmaceuticals. K. Cook: Consultant; Self; Aegerion Pharmaceuticals. D. Gupta: Consultant; Self; Aegerion Pharmaceuticals. D. Holmqvist: Consultant; Self; Aegerion Pharmaceuticals. D. Lee: Consultant; Self; Aegerion Pharmaceuticals. C.K. Ng: Consultant; Self; Aegerion Pharmaceuticals. P. Bradt: Employee; Self; Aegerion Pharmaceuticals. R. Brown: None.