Managing diabetes remotely: Evaluation of the uptake and efficacy of the DBm app

Objectives: Insulin optimisation requires review of glucose monitoring;Covid-19 posed challenges to this. We evaluated DBm -a remote monitoring platform utilising a glucometer and smartphone app. Method(s): Evaluation was from January to November 2021. Inclusion criteria was insulin treated diabetes with HbA1c greater than 68mmol/mol. HbA1c, demographics, frequency of CBG uploads and interactions with clinicians were collected. Result(s): 97 patients were offered DBm. 48.5% used the app. There were no statistically significant differences in gender (p = 0.05), age (p = 0.36), type of diabetes (p = 0.13) or deprivation index (p = 0.96) between users and non-users. Patients of white ethnicity were less likely to use the platform (p = 0.01). Amongst users, 70% had a reduction of HbA1c of at least 5mmol/mol over six months, with a mean reduction of 25.6mmol/mol (p = 0.01). There was no difference in age (p = 0.64), gender (p = 0.4), and type of diabetes (p = 0.23) between responders and non-responders. There was also no difference in number of call back requests generated by patients (p = 0.32) or number of CBG uploads (p = 0.899) between responders and non-responders. Conclusion(s): Uptake of the remote monitoring solution was just under 50%, with no evidence of digital exclusion, although the finding that white ethnicity patients were less likely to use the system needs further exploration. Most users had improved glucose control, but there was no association with numbers of tests or call back requests. This study demonstrates that insulin optimisation can effectively be delivered using a remote glucose monitoring system. Future work will explore patient experience and patient satisfaction.

Social Isolation and Social Support Among Young Adult Vs. Older Adult Cancer Survivors during One Year of the COVID-19 Pandemic: A Propensity Score Matched Analysis

Background/Purpose: Social isolation is associated with worse outcomes among cancer survivors, whereas social support is protective. Social factors are particularly important to evaluate among young adult (YA) cancer survivors aged 18-39 given the rapid social development that occurs during young adulthood, and social isolation may have been exacerbated during the COVID-19 pandemic. We examined differences in social isolation and social support among YA vs. older adult cancer survivors (aged >=40) across one year of the COVID-19 pandemic. Method(s): Participants were recruited to a large cohort study from 11/2020 to 02/2021. PROMIS short forms were used to assess social isolation at enrollment, 2-months, 6-months, and 10-months, and social support (i.e., emotional, instrumental, and informational support and companionship) at 2-months, 4-months, 6-months, 8-months, and 12-months. Propensity score matching to nearest neighbor was used to match YAs with older adult cancer survivors based on demographic and clinical characteristics. Multilevel models were used to evaluate the effects of age (YA vs. older adult), time (month), and the interaction of age and time on social isolation and social support. Result(s): In total, 504 participants were included (252 matched pairs). Most were female (70%), White (81%), and non-Hispanic (83%). YAs were M = 33.6 years (SD = 4.5) and older adults were M = 58.8 years (SD = 10.4). Across age groups and time, average scores for social isolation and social support were within normal ranges. YAs reported more social isolation than older adults (Mpooled = 48.7 and 45.8, respectively;Beta = 2.50, p < 0.01), and social isolation and companionship decreased similarly for YAs and older adults (Beta = -0.12, p = 0.04 and Beta = -0.12, p = 0.02, respectively). No other associations were observed. Conclusions and Implications: YA cancer survivors reported more social isolation than older adults during the COVID-19 pandemic, though differences were small and not clinically meaningful. Future studies should identify patient characteristics associated with high social isolation and low social support to identify subgroups that may benefit from intervention.

REACHING PROGRAM OUTCOMES DURING PANDEMIC: English Language Teacher Professional Development in Uzbekistan

Achieving effective English language teacher professional development (PD) in global contexts calls for a broad understanding of program implementation complexities, including cultural, linguistic, and logistical considerations, particularly with international partners and stakeholders. The organization and administration of a three-year, country-wide in-service teacher PD program in Uzbekistan became more complex when COVID-19 restricted travel by the U.S. partners. Instead of postponing the program, partners and stakeholders found avenues that would still propel them toward achieving intended program outcomes and deliverables. This chapter explores a U.S.-based university's flexible, creative response to the pandemic's restrictions and explains how program administration, from a university partner perspective, could produce innovations in English language teacher and teacher leadership development. Although this chapter includes context specific examples, implications are drawn to guide any administrator of English language teacher education programs with diverse stakeholders. The following key elements were considered central to the success of this international project: 1) commitment to contextual and cultural sensitivity;2) diverse team building;3) asset-based approaches to teacher development;and 4) technological readiness for diverse contexts and communication modes. These elements lay the foundation for effectively reimagining an international program for English language teachers in the face of a pandemic. © 2023 Taylor and Francis.

Safety and clinical efficacy outcomes from the Long-term extension study of tolebrutinib in patients with relapsing multiple sclerosis: 2-year results

Introduction: Phase 2b trial (NCT03889639) findings in patients with relapsing multiple sclerosis showed central nervous systempenetrant Bruton's tyrosine kinase inhibitor tolebrutinib was well tolerated over 12 weeks and elicited dose-dependent reductions in new gadolinium-enhancing T1 and new/enlarging T2 lesions. Objective/Aim: To characterise tolebrutinib's safety and efficacy at Week 96 (2 years) in the phase 2b trial's long-term safety (LTS) extension (NCT03996291). Method(s): In LTS extension Part A, patients continued their core study tolebrutinib dose (5, 15, 30, or 60 mg/day) double-blind until the phase 3 study dose selection (60 mg/day). In Part B, patients received open-label tolebrutinib 60 mg/day. Safety was assessed via adverse event (AE) reporting. Efficacy outcomes included annualised relapse rate (ARR) and change from baseline Expanded Disability Status Scale (EDSS) score. Result(s): 124 of 125 patients completed Part A and transitioned to Part B;114 (90.5%) remained on study as of 7 March 2022. One patient receiving tolebrutinib 5 mg/day discontinued Part A because of progressive disease and 10 discontinued Part B because of AEs (n=3), perceived lack of efficacy (n=4), emigration (n=2), and patient decision (n=1). At Week 96, no new safety signals have been observed. The most common treatment-emergent AEs (TEAEs) were COVID-19 (20.8% [26/125]), headache (13.6% [17/125]), nasopharyngitis and upper respiratory tract infection (both 11.2% [14/125]), bacterial cystitis (7.2% [9/125]), and pharyngitis and arthralgia (both 5.6% [7/125]). No tolebrutinib dose effects for TEAEs or serious AEs were observed in Part A and no safety signals emerged for patients switching to tolebrutinib 60 mg/day in Part B. Of those who received tolebrutinib 60 mg/day for a minimum of 8 weeks, ARR was 0.17 (95% CI: 0.12, 0.25) and 80.6% remained relapse-free. Mean EDSS remained stable to Week 96. Conclusion(s): Through LTS Week 96, tolebrutinib 60 mg/day continues to show favourable safety, and is associated with a low ARR and stable disability status.

MRI, efficacy, and safety of tolebrutinib in patients with highly active disease (HAD): 2-year data from the phase 2b Long-term safety (LTS) Study

Intoduction: In the phase 2b trial (NCT03889639), brain-penetrant Bruton's tyrosine kinase inhibitor tolebrutinib was well tolerated with dose-dependent reductions in new/enlarging MRI lesions. Objective/Aim: Report MRI, efficacy, and safety outcomes at Week (W)96 (2 years) of the phase 2b trial long-term safety (LTS) extension (NCT03996291) in relapsing MS patients with highly active disease (HAD). Method(s): In the double-blind portion of LTS (Part A), patients continued their core study tolebrutinib dose (5, 15, 30, or 60 mg/day). In the open-label Part B, all participants received 60 mg/day. HAD was defined as one relapse in the year prior to screening and one of the following: >1 gadolinium (Gd)- enhancing lesion within the prior 6 months, or >=9 T2 lesions at baseline (BL) or >=2 relapses in the prior year. Outcomes included Gd-enhancing and new/enlarging T2 lesions, annualized relapse rate (ARR), and Expanded Disability Status Scale (EDSS) score. Result(s): 61 patients met the HAD criteria at BL;60 continued in LTS Part A and 59 transitioned to Part B. As of 7 March 2022, 55 (92%) patients remained on study. New Gd-enhancing lesion counts remained low in the 60/60-mg arm through W96 and were reduced in other arms by W48 through W96, except for 5/60 at W96 (mean+/-SD at W96: 2.00+/-3.83, 0.56+/-1.04, 0.47+/-1.13, 0.23+/-0.44 in 5/60-, 15/60-, 30/60-, 60/60-mg arms, respectively). New/enlarging T2 lesion counts remained low for 15/60, 30/60, and 60/60 mg. T2 lesion volume remained unchanged for 60/60 mg. The most common treatment-emergent adverse events (TEAE) were COVID-19 (20%), nasopharyngitis (16.7%), headache (13.3%), and upper respiratory tract infection (8.3%). There was no dose-relationship for TEAE/serious AE in Part A and no new safety findings for patients switching to 60 mg in Part B. Of the patients who received tolebrutinib 60 mg/day for a minimum of 8 weeks, ARR was 0.10 (95% CI: 0.02, 0.66) and 92.9% remained relapse-free at W96. Mean EDSS scores were stable through W96. Conclusion(s): Through LTS Week 96, in the HAD cohort, tolebrutinib 60 mg demonstrated favourable safety (similar to the overall population), tolerability, and low ARR. New Gd-enhancing lesion counts remained low for the 60/60-mg arm.

ICU and Beyond -establishing a virtual post ICU rehabilitation class. Supporting life after ICU for patients and family

Introduction: A high proportion of patients surviving critical illness have significant, continuing problems characterised by weakness, loss of energy, physical difficulties, anxiety, depression, post-traumatic stress, and for some, impaired cognitive function.1 Enhancing survivorship, and the quality of survival, is now central to the management of critically unwell patients.2 Rehabilitation should be multiprofessional, interdisciplinary and coordinated across the recovery continuum from ICU to the patients' home to optimise patient outcome, increase quality of survival, and promote living and thriving as opposed to just surviving. A quality improvement project developing ICU therapy supported discharges in Northern Devon Healthcare Trust identified that access to community rehabilitation services was a limitation to optimising recovery after ICU. In 2020 the access to rehabilitation services was further challenged by the Covid-19 pandemic. An MDT rehabilitation class to continue supporting ICU patients following discharge from hospital was identified as an option for improving patient experience and outcomes. Outpatient rehabilitation classes delivered by the ICU care team were postulated to provide benefits such as continuity of care, timely access and provide peer support whilst complimenting community services. Objectives: • To test the effectiveness of an ICU rehabilitation class on patient outcomes • To establish the patient acceptability and experience of an ICU rehabilitation class Methods: A test of change methodology was used to pilot a virtual ICU rehabilitation class in 2020 during the Covid-19 pandemic. Level 3 ICU patients who had a prolonged ICU stay of greater than one week and had extensive rehabilitation needs were identified via the current Covid-19 caseload, the ICU follow-up clinic and from the caseload of the wider ICU supported discharge quality improvement project. A virtual rehabilitation class was designed including a pre and post assessment using either Attend Anywhere, telephone and a Zoom based class for one hour twice a week for six weeks. Each one hour class included 30 mins exercise and 30 mins education. MDT delivered education topics included delirium, benefits of exercise, nutrition, speech, breathlessness, pacing, mindfulness and a Q&A session with a consultant. A broad range of patient outcomes were assessed (Table 1) and a focus group was held following the class to gain feedback on the experience and to inform the evolution of the service design. Results: Nine patients were identified that met the inclusion criteria and six consented to participate in the class. Improvements were demonstrated across the range of outcome measures (Table 1). Themes arising from the focus group discussion included an overall feeling of benefit, appreciation of the opportunity to share experiences with others in a similar position and reflection on the option to complete the course online. Conclusion: A virtual rehabilitation class was well received by patients with improvements shown in both physical and mental wellbeing. Following patient feedback, a further test of change may consider a combination of face to face and virtual class delivery.

Safety and Clinical Efficacy Outcomes From the Long-term Extension Study of Tolebrutinib in Patients With Relapsing Multiple Sclerosis:18-Month Results

Objective: To describe safety and efficacy of tolebrutinib in patients with relapsing multiple sclerosis at Week 72 (Month 18) in the long-term safety (LTS) extension of the phase 2b trial. Background: In the phase 2b trial (NCT03889639), tolebrutinib, a CNS-penetrant Bruton's tyrosine kinase inhibitor, was well tolerated over 12 weeks with dose-dependent reduction in new gadolinium-enhancing T1 and new/enlarging T2 lesions. Design/Methods: The LTS extension (NCT03996291) consists of 2 parts: patients continued their core study tolebrutinib dose (5, 15, 30, or 60 mg/day) double-blind until the phase 3 study dose was selected (Part A), and currently receive tolebrutinib 60 mg/day open-label (Part B). Long-term safety and tolerability is the primary objective. Secondary endpoints include annualized relapse rate (ARR) and change from baseline in Expanded Disability Status Scale (EDSS) score. Results: 124 of 125 patients treated in the extension completed Part A and transitioned to Part B. One patient (on 5 mg/day) discontinued Part A due to progressive disease and 6 discontinued Part B due to a variety of reasons, including adverse event (AE;n=2), lack of efficacy (n=1), progressive disease (n=1), and emigration (n=2). To date, no new safety signals have been observed. The most common treatment-emergent AEs (TEAEs) were headache (12.8% [16/125]), COVID-19 (12.8% [16/125]), nasopharyngitis (10.4% [13/125]), upper respiratory tract infection (8.0% [10/125]), and arthralgia (5.6% [7/125]). There was no suggestion of a dose effect for TEAE or serious AE in Part A and no emergence of new safety signals for patients switching to 60 mg in Part B. ARR on tolebrutinib 60 mg was 0.17 (95% CI: 0.11, 0.27);84.7% of patients were relapse-free at the LTS Week 72 cut-off. Mean EDSS scores remained stable to LTS Week 72. Conclusions: Through LTS Week 72, tolebrutinib 60 mg continues to show favorable safety and tolerability, and low ARR.

POST COVID NEUROPATHIC PAIN: A CASE REPORT

COVID-19 has been reported to be associated with various neurological manifestations involving both the central and peripheral nervous system. Somatic and visceral pain, as well as headache, are all widely recognised in association with COVID-19, however, there is a comparative paucity of reports of neuropathic pain. We present a case of COVID-19 associated neuropathic pain in a 61-year-old male. He developed acute severe burning pain affecting all four limbs distally, one week following confirmed COVID-19 infection. There was no ataxia or autonomic failure. Neurological examination was unremarkable. Electrophysiologi-cal tests revealed delayed SSEP in the lower limbs, however, skin biopsy and MRI of the neuroaxis was unremarkable. His pain was inadequately controlled with gabapentin but improved significantly after a short course of steroids. This case adds to the various neurological manifestations of COVID-19 infection, highlighting the possible variability of symptoms in patients with nervous system involvement of SARS-CoV-2 infection. This report provides additional evidence that COVID-19 disease can trigger autoimmunity which is consistent with previous reports of several autoimmune neurological diseases.

COVID-19 in neuromyelitis optica spectrum disorders and myelin oligodendrocyte glycoprotein antibody disease patients in North America;COViMS registry

Introduction: The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) raised concerns about the risks of COVID-19 in those with neuroimmunological disorders that affect the central nervous system. Risk factors associated with worse COVID-19 outcomes in MS have been identified. However, little data has been reported on how COVID-19 impacts people with neuromyelitis optica spectrum disorders (NMOSD) and myelin oligodendrocyte glycoprotein antibody disease (MOGAD). Objective: To assess whether the COVID-19 Infections in MS and Related Diseases (COViMS) Registry provides information on the impact of COVID-19 on people with NMOSD and MOGAD. Aims: To describe the clinical characteristics, risk factors for severe course of COVID-19, and overall COVID-19 outcomes in patients with NMOSD and MOGAD. Methods: The COViMS Registry collected data on North American patients with MS and related diseases with laboratory positive or highly suspected SARS-CoV-2 infection. De-identified data were entered into a web-based registry by health care providers. Data were analyzed using t-tests, Pearson's chi-square or Fisher's Exact tests for categorical variables. Univariate logistic regression models examined effects of risk factors and COVID-19 clinical severity. Results: As of April 1, 2021, 66 NMOSD and 15 MOGAD patients were reported in the COViMS Registry. Most NMOSD patients were laboratory positive for SARS-CoV-2 and taking rituximab at time of COVID-19 diagnosis. Most NMOSD patients were not hospitalized (66.7%[95%CI:54.0-77.8%]), while 12.1% (95%CI:5.4-22.5%) were hospitalized only, 9.1% (95%CI:3.4-18.7%) were admitted to the ICU and/or ventilated, and 12.1% (95%CI:5.4-22.5%) died. In NMOSD patients, having a comorbidity was the sole factor identified for poorer COVID-19 outcome (OR=6.3, 95%CI:1.64-24.52). Most MOGAD patients were laboratory positive for SARS-CoV-2 and almost half were taking rituximab. Among MOGAD patients, 73.3% were not hospitalized and no deaths were recorded;no factors were different between those not hospitalized versus those hospitalized, admitted to the ICU, or ventilated. Conclusion: Among the reported NMOSD patients, a high mortality rate was observed and presence of comorbid conditions were associated with worse COVID-19 outcome. MOGAD patients appear to fare better than NMOSD patients, with fewer reported with severe COVID-19 outcome and no reported deaths.

Safety and efficacy outcomes from the long-term extension study of tolebrutinib in patients with relapsing MS: Year 1 results

Introduction: Tolebrutinib is a covalent, irreversible, central nervous system (CNS)-penetrant Bruton's tyrosine kinase inhibitor targeting B lymphocytes and myeloid cells (eg, macrophages and microglia), thereby modulating innate and adaptive immunity in the periphery and CNS. Results from the phase 2b trial (NCT03889639) demonstrated that tolebrutinib was well tolerated over a 12-week period and identified a dose-dependent reduction in new gadolinium-enhancing T1 lesions and new/ enlarging T2 lesions in people with relapsing MS (pwRMS);the selected dose was 60 mg/day. Patients who completed the tolebrutinib phase 2b trial were eligible for enrolment in the ongoing long-term safety and efficacy extension study (NCT03996291). Aims: Describe the safety and efficacy of tolebrutinib in pwRMS at 48 weeks in the long-term extension study. Methods: The extension study consisted of 2 parts: in Part A, participants continued double-blind treatment with the same tolebrutinib dose as administered in the core study (5, 15, 30 or 60 mg/ day);in Part B, participants received open-label treatment with the 60-mg dose, which is being tested in the phase 3 trials GEMINI 1 (NCT04410978) and GEMINI 2 (NCT04410991). Safety was the primary endpoint. Secondary endpoints included clinical efficacy outcomes (annualised relapse rate and change from baseline in Expanded Disability Status Scale score). Results: Of 130 participants randomised in the phase 2b trial, 129 completed the core study and 125 enrolled in the long-term extension study. Of these participants, 2 (2%) discontinued due to adverse events and 1 (1%) was lost to follow-up as of 5 March, 2021. To date, no new safety signals have been observed over the duration of exposure in this study. The most common treatmentemergent adverse events occurring in & ge;5% of participants were headache (10% [13/125]), COVID-19 (9% [11/125]), upper respiratory tract infection (8% [10/125]) and nasopharyngitis (7% [9/125]). There was no suggestion of a dose effect for treatmentemergent or serious adverse events in Part A and no emergence of new safety signals for participants who switched to the 60-mg dose. The analysis of clinical efficacy outcomes is ongoing and will be presented at the meeting. Conclusions: Safety data from the long-term extension study of tolebrutinib in pwRMS continue to show favourable tolerability, without the emergence of any new safety signals.

Pivoting in the Time of COVID-19: An in-Depth Case Study at the Nexus of Food Insecurity, Resilience, System Re-Organizing, and Caring for the Community

According to the School Nutrition Association, nearly 100,000 schools serve free or reduced school lunches and breakfasts daily to approximately 34. 34 million students nationwide. However, as COVID-19 forced many schools to close, students who depended on the public schools to meet the majority of their nutritional needs faced an even larger battle with food insecurity. Recognizing this unmet need, and that food insecurity was intertwined with other needs within the community, the Crystal Bridges Museum of American Art and its satellite contemporary art space the Momentary, partnered with the Northwest Arkansas Food Bank and over 30 additional partner organizations to pivot their existing outreach services. In this case study, we identify lessons learned by Crystal Bridges that might be useful for other organizations who seek to foster meaningful engagement with the public, especially in times of crisis. Specifically, we focus on three main lessons: 1) how the museum created a plan to learn through the pivot in order to capture their own lessons, 2) how the members of the organization experienced a sense of coming together (congregation) during the pivot, and 3) how the organization planned to improve both internal and external communication.

A mixed methods protocol to evaluate the effectiveness and acceptability of COVID-19 Community Assessment Hubs

Background: Ireland's health system has been under significant strain due to staff shortages and inadequate capacity. Critical care bed capacity per capita in Ireland is among the lowest in Europe, thus, the coronavirus disease 2019 (COVID-19) pandemic has put additional strain on an over-stretched system. COVID-19 Community Assessment Hubs (CAHs) were established to mitigate unnecessary admission to acute hospitals, and reduce infection spread by supporting COVID-19 positive or suspected positive patients to isolate at home, or in isolation facilities. There is some evidence that similar assessment centres may be a successful triage strategy to reduce burden on hospital and acute care. Aim : The aim of this study is to evaluate the impact of COVID-19 Community Assessment Hubs on service delivery in one region in Ireland. Methods: A mixed-methods approach will be used, incorporating co-design to engage stakeholders and ensure informed data capture and analysis. Online surveys will assess CAH patients' experiences of access to and quality of care. Clinical patient data from CAHs will be collected and analysed using multinomial logistic regression to check for association with patient demographics and COVID-19 symptoms, and CAH early warning scores and outcomes (Transfer to Emergency Department, Transfer to isolation unit, Sent home with care plan). Semi-structured interviews will be conducted with: patients to elicit an in-depth understanding of experiences and acceptability of attending CAHs;and staff to understand challenges, benefits, and effectiveness of CAHs. Interview data will be analysed using a thematic analysis approach. Discussion: This study will provide valuable insights from both patient and staff perspectives on the operation of CAHs. We will evaluate the effectiveness and acceptability of CAHs and propose areas for improvement of the service. This will contribute to international literature on the use of community assessment centres during infectious disease pandemics.

Top-line results of emphasis, a phase 2 clinical trial of vidofludimus calcium (IMU-838) in relapsing-remitting multiple sclerosis

Background: Dihydroorotate dehydrogenase (DHODH) inhibition is an established mode of action for disease-modifying treatment of relapsing-remitting multiple sclerosis (RRMS). Vidofludimus calcium (IMU-838) is a selective and potent second- generation DHODH oral immunomodulator being developed for the treatment of several immune-mediated diseases including MS and COVID-19. The inhibition of the DHODH enzyme leads to metabolic stress in stimulated lymphocytes with subsequent reduction of pro-inflammatory cytokines and induction of apoptosis. Due to IMU-838's pharmacological selectivity and lack of relevant off-target effects on kinases, increased rates of typical antiproliferative effects (neutropenia, alopecia and gastrointestinal disturbances) have not been observed in clinical trials. The serum half-life of approximately 30 hours allows quick on- and off-dosing. Objectives: To report topline efficacy, safety, and tolerability of IMU-838 in the relapsing MS EMPhASIS trial (NCT03846219), the first trial of IMU-838 in MS. Methods: EMPhASIS is a phase 2 multicenter, double-blind, placebo-controlled, randomized, parallel-group trial to assess the efficacy and safety of two once-daily oral doses of IMU-838 (30 and 45 mg/day) in patients with RRMS. Inclusion criteria are age 18-55 years, active RRMS defined by the evidence of clinical and radiological disease activity, and Expanded Disability Status Scale (EDSS) 0-4. The primary endpoint is the cumulative number of combined unique active MRI lesions over 24 weeks. Secondary endpoints include efficacy, safety and tolerability parameters. The study also includes a subsequent optional, open-label treatment period to evaluate long-term safety and tolerability. Results: 210 subjects (65% women) were enrolled in 36 centers across four European countries. The mean age at baseline was 36.8 years (SD 8.8). 198 subjects (94%) completed the 24-week main treatment period, with the last follow-up visit in April 2020. Database lock will be in July 2020 and top-line data will be available shortly thereafter. Primary outcome and several secondary outcomes (including safety data) will be presented. Conclusions: IMU-838 is an orally available, next-generation selective immunomodulator with a potentially more favorable profile than first-generation DHODH inhibitors. Top-line results of IMU-838 on primary and several secondary endpoints in patients with RRMS in the EMPhASIS trial will be presented.