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The effects of N2 and O2:N2 (1:1) as ambient gases during activation annealing of Mg as p-type doping of GaN have been investigated. The purpose was to understand the mechanisms involved and especially the impact of O2 on the resulting hole concentration and hole mobility. The addition of O2 to the ambient gas during annealing is known to be very effective in reducing the H level of the Mg-doped GaN layer, but the maximum achievable hole concentration and mobility, as determined by Hall characterization, is still higher with pure N2. The difference is explained by an in-diffusion of O to the GaN layer acting as n-dopant and thus giving rise to a compensation effect.It is found that to a large degree only the Mg-H complexes at substitutional (MgGa), i.e., the electrically active acceptor sites that provide free holes, are activated by annealing with N2 only as ambient gas, while annealing with O2:N2 (1:1) also dissociates electrically inactive Mg-H complexes resulting in much less residual H. Thus, the residual H level in relation to the Mg level after activation annealing with N2 only may provide a representative measure of the resulting free hole concentration of the Mg-doped GaN layer.

The EIT Climate-KIC SATURN project deals with rural-urban territories, their landscapes and environmental challenges. The land of our cities and regions is fragmented and prone to several challenges in terms of ecology, governance and social coherence. As a result of unregulated overlapping of different land uses and complex governance patterns, landscape fragmentation creates severe challenges in the ways the land is perceived, identified and therefore managed. The SATURN consortium is working on different models to help address the governance and decision-making process and support on a policy level by applying holistic ideas of visioning and stakeholder engagement at a city scale. The diversity of the three hubs (Birmingham in central England, Gothenburg in western Sweden, and Trentino in northern Italy) is reflected by their approaches to stakeholders’ engagement and visioning processes as well as especially adopted activities in each location. Within the SATURN project, we are investigating how these approaches could change perceptions and impact on landscape strategic actions. Through a series of especially designed workshops on landscape visioning and stakeholder engagement, the project aims to create a toolbox supporting urban, peri-urban and regional planning. This paper reports on the visioning and stakeholder mapping and analysis tools, and shares examples where these processes were tested during the broader SATURN scheme. Results demonstrate how the visioning exercise has changed public perceptions about an area and how this has affected the decision-making process of each city towards a more effective planning of sustainable landscapes. The stakeholder engagement activity demonstrates the importance of “mapping and analysis” of the various actors involved in a city and the ways a landscape project can effectively engage with them and seek further collaboration. Questions on how the results differ in cases where the stakeholder engagement process focused on a broad policy level or targeted specific actions for a certain region are being explored. Both the visioning and stakeholder engagement tools are subject to a holistic approach and a collaborative and open process between the stakeholders and the trainers, allowing the participants to build a vision for their regions and be one-step closer to systemic change.

Abstract Plasma membrane repair is essential for eukaryotic cell life and is triggered by the influx of calcium through membrane wounds. Repair consists of sequential steps, with closure of the membrane hole being the key event that allows the cell to recover, thus identifying the kinetics of hole closure as important for clarifying repair mechanisms and as a quantitative handle on repair efficiency. We implement calcium imaging in MCF7 breast carcinoma cells subject to laser damage, coupled with a model describing the spatio-temporal calcium distribution. The model identifies the time point of hole closure as the time of maximum calcium signal. Analysis of cell data estimates the closure time as: $$\langle t_c \rangle =5.45\pm 2.25$$ ⟨ t c ⟩ = 5.45 ± 2.25 s and $$\langle t_c \rangle =6.81\pm 4.69$$ ⟨ t c ⟩ = 6.81 ± 4.69 s using GCaMP6s-CAAX and GCaMP6s probes respectively. The timescale was confirmed by independent time-lapse imaging of a hole during sealing. Moreover, the analysis estimates the characteristic time scale of calcium removal, the penetration depth of the calcium wave and the diffusion coefficient. Probing of hole closure times emerges as a strong universal tool for quantification of plasma membrane repair

I Sociologisk Forskning har undervisning och lärande tidigare diskuterats på flera sätt. Ämnet har bland annat behandlats i forskningsartiklar som undersökt skolbarns välbefinnande och utbildningsresultat (Aytar & Mella 2012), hinder för tillgång till högre utbildning (Ismail 2011), professionsutmaningar inom gymnasieutbildningen (Bruno 2012) och strukturella bestämningsfaktorer för akademiska karriärer (Behtoui 2017). Den sociologiska forskningspraktikens nära koppling till ämnets pedagogiska praktik har också medfört att personliga undervisningserfarenheter behandlats i olika texter (se specialnumret ”Sociologi i tiden”: Hansen, Johansson, Kollind m.fl. 1997). Tidskriftens redaktion skulle framöver gärna se fler artiklar som behandlar frågor om undervisning och lärande inom sociologiämnet. Vi välkomnar därför sociologikollegor att inkomma med förslag till sådana artiklar eller färdiga manus. Det skulle kunna vara texter om hur vår praktik som sociologer påverkar vårt sätt att undervisa, hur sociologisk forskning omsätts i undervisning, hur olika pedagogiska metoder och material kan användas i sociologiundervisningen eller hur samhälleliga processer och strukturer påverkar vad som händer i klassrummet. Vi tror att sådana reflektioner med fördel skulle kunna ta sin utgångspunkt i utbildningssociologi och den svenska sociologins reflekterande tradition. Som ett första steg mot att ge utrymme åt denna typ av artiklar publicerar vi i detta nummer ett samtal om hur undervisningen i sociologi har påverkats av övergången till digital undervisning under covid-19-pandemin. Vi bad fyra sociologikollegor, verksamma vid olika svenska lärosäten, att svara på några frågor utifrån sina erfarenheter som lärare, utbildningssamordnare och forskare. De medverkande är Martin Berg, professor i medieteknik och docent i sociologi vid Malmö universitet, som forskar om digital sociologi med särskilt fokus på kritiska studier av algoritmer och automatiseringsprocesser; Ida Lidegran, docent i utbildningssociologi vid Uppsala universitet, som ingår i Forskningsgruppen för utbildnings- och kultursociologi (SEC) och forskar om elitutbildningar och familjers utbildningsstrategier, migranters möte med det svenska utbildningssystemet samt utbildning och covid-19; Ulrika Schmauch, lektor i sociologi vid Umeå universitet, vars forskning handlar om social ojämlikhet i allmänhet och om ras, plats och kön i synnerhet; samt Glenn Sjöstrand, prefekt för Institutionen för samhällsstudier vid Linnéuniversitetet i Växjö, vars forskning i huvudsak är inriktad mot professionsstudier och särskilt ingenjörers professionella utveckling, men som även forskar om digital transformation, miljö och välfärdsfrågor.

Abstract We present a case with a phototoxic reaction following topical use of NSAID. The phototoxic reaction was initially mistaken for cellulitis which led to treatment with dicloxacillin, which led to an exanthematous drug eruption. The patient was treated with topical clobetasol propionate and oral non‐sedating antihistamines. Follow‐up revealed post‐inflammatory hypopigmentation.

The aim of this study was to investigate if there was an association between infarct size (IS) measured by cardiac magnetic resonance (CMR) and echocardiographic global longitudinal strain (GLS) in the early stage of acute myocardial infarction in patients with preserved left ventricular ejection fraction (LVEF). Patients with ST-segment elevation myocardial infarction who underwent primary percutaneous coronary intervention were assessed with CMR and transthoracic echocardiogram within 1 week of hospital admission. Two-dimensional speckle tracking was performed using a semi-automatic algorithm (EchoPac, GE Healthcare). Longitudinal strain curves were generated in a 17-segment model covering the entire left ventricular myocardium. GLS was calculated automatically. LVEF was measured by auto-LVEF in EchoPac. IS was measured by late gadolinium enhancement CMR in short-axis views covering the left ventricle. The study population consisted of 49 patients (age 60.4 ± 9.7 years; 92% male). The study population had preserved echocardiographic LVEF with a mean of 45.8 ± 8.7%. For each percent increase of IS, we found an impairment in GLS by 1.59% (95% CI 0.57–2.61), P = 0.02, after adjustment for sex, age and LVEF. No significant association between IS and echocardiographic LVEF was found: −0.25 (95% CI: −0.61 to 0.11), P = 0.51. At the segmental level, the strongest association between IS and longitudinal strain was found in the apical part of the LV: impairment of 1.69% (95% CI: 1.14–2.23), P < 0.001, for each percent increase in IS. In conclusion, GLS was significantly associated with IS in the early stage of acute myocardial infarction in patients with preserved LVEF, and this association was strongest in the apical part of the LV. No association between IS and LVEF was found.

Objective: There is strong evidence that medication adherence and lifestyle changes are essential in patients undergoing secondary cardiovascular disease prevention. Cardiac rehabilitation (CR) increases medication adherence and improves lifestyle changes. Patients with cardiac diseases and a low educational level and patients with little social support are less responsive to improve medication adherence and to adapt lifestyle changes. The aim of the present study was to investigate the long-term effects of a socially differentiated CR intervention on medication adherence as well as changes in biological and lifestyle risk factors at two- five- and ten-year follow-up. Design: A prospective cohort study. Setting: The cardiac ward at Aarhus University Hospital, Denmark. Intervention: A socially differentiated CR intervention in addition to the standard CR program. Subjects: Patients admitted with first-episode myocardial infarction between 2000 and 2004, N = 379. Patients were defined as socially vulnerable or non-socially vulnerable according to their educational level and extent of social network. Main outcome measures: Primary outcome was medication adherence to antithrombotics, beta-blockers, statins and angiotensin-converting enzyme inhibitors. Secondary outcomes were biological and lifestyle risk factors defined as; total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, glycated hemoglobin, blood pressure and smoking status. Results: No significant long-term effect of the intervention was found. Conclusions: The results indicate a non-significant effect of the intervention. However, it was found that equality in health was improved in the study population except concerning smoking. General practitioners manage to support the long-term secondary cardiovascular disease prevention in all patients regardless of social status.Key points The socially differentiated intervention did not significantly improve medication adherence or biological and lifestyle risk factors. Despite the non-significant effect of the intervention, equality in health was improved except concerning smoking. General practitioners managed to support the long-term secondary cardiovascular disease prevention in all patients regardless of social status.

Background and Purpose: Radiodermatitis is a well-known toxicity of radiotherapy and barrier film has been shown to reduce the severity of radiodermatitis. We have validated prior findings in a Danish cohort, using a similar barrier film and patient reported outcomes. Materials and Methods: 101 Danish breast cancer patients were included at three radiotherapy centres. Based on randomization either the lateral or medial part of their chest was covered by Mepitel film; making the patients their own control. The primary endpoint was patient reported symptoms and experience. A secondary endpoint was radiotherapy staff evaluation of dermatitis. Results: Within the skin area covered by film, the patients reported a statistical significant lower level of pain (p

G-protein-coupled receptor-35 (GPR35) has been identified as a receptor for the tryptophan metabolite kynurenic acid (KynA) and suggested to modulate macrophage polarization in metabolic tissues. Whether GPR35 can influence vascular inflammation and atherosclerosis has however never been tested. Lethally irradiated LdlrKO mice were randomized to receive GPR35KO or wild type (WT) bone marrow transplants and fed a high cholesterol diet for eight weeks to develop atherosclerosis. GPR35KO and WT chimeric mice presented no difference in the size of atherosclerotic lesions in the aortic arch (2.37 ± 0.58% vs. 1.95 ± 0.46%, respectively) or in the aortic roots (14.77 ± 3.33% vs. 11.57 ± 2.49%, respectively). In line with these data, no changes in the percentage of VCAM-1+, IAb + cells, and CD3+ T cells, as well as alpha smooth muscle cell actin expression, was observed between groups. Interestingly, the GPR35KO group presented a small but significant increase in CD68+ macrophage infiltration in the plaque. However, in vitro culture experiments using bone marrow-derived macrophages from both groups indicated that GPR35 plays no role in modulating the secretion of major inflammatory cytokines. Our study indicates that GPR35 expression does not play a direct role in macrophage activation, vascular inflammation, and the development of atherosclerosis.

The effect of Atlas-based automated segmentation (ABAS) on dose volume histogram (DVH) parameters compared to manual segmentation (MS) in loco-regional radiotherapy (RT) of early breast cancer was investigated in patients included in the Skagen Trial 1. This analysis supports implementation of ABAS in clinical practice and multi-institutional trials.

Abstract not available.

We present the first study to examine the year-round distribution, activity patterns, and habitat use of one of New Zealand's most common seabirds, the fluttering shearwater (Puffinus gavia). Seven adults from Burgess Island, in the Hauraki Gulf, and one individual from Long Island, in the Marlborough Sounds, were successfully tracked with combined light-saltwater immersion loggers for one to three years. Our tracking data confirms that fluttering shearwaters employ different overwintering dispersal strategies, where three out of eight individuals, for at least one of the three years when they were being tracked, crossed the Tasman Sea to forage over coastal waters along eastern Tasmania and southeastern Australia. Resident birds stayed confined to waters of northern and central New Zealand year-round. Although birds frequently foraged over pelagic shelf waters, the majority of tracking locations were found over shallow waters close to the coast. All birds foraged predominantly in daylight and frequently visited the colony at night throughout the year. We found no significant inter-seasonal differences in the activity patterns, or between migratory and resident individuals. Although further studies of inter-colony variation in different age groups will be necessary, this study presents novel insights into year-round distribution, activity patterns and habitat use of the fluttering shearwater, which provide valuable baseline information for conservation as well as for further ecological studies.

The plasma membrane surrounds every single cell and essentially shapes cell life by separating the interior from the external environment. Thus, maintenance of cell membrane integrity is essential to prevent death caused by disruption of the plasma membrane. To counteract plasma membrane injuries, eukaryotic cells have developed efficient repair tools that depend on Ca2+- and phospholipid-binding annexin proteins. Upon membrane damage, annexin family members are activated by a Ca2+ influx, enabling them to quickly bind at the damaged membrane and facilitate wound healing. Our recent studies, based on interdisciplinary research synergy across molecular cell biology, experimental membrane physics, and computational simulations show that annexins have additional biophysical functions in the repair response besides enabling membrane fusion. Annexins possess different membrane-shaping properties, allowing for a tailored response that involves rapid bending, constriction, and fusion of membrane edges for resealing. Moreover, some annexins have high affinity for highly curved membranes that appear at free edges near rupture sites, a property that might accelerate their recruitment for rapid repair. Here, we discuss the mechanisms of annexin-mediated membrane shaping and curvature sensing in the light of our interdisciplinary approach to study plasma membrane repair.

To quantify the contribution of changes in different risk factors population levels and treatment uptake on the decline in CHD mortality in Denmark from 1991 to 2007 in different socioeconomic groups.We used IMPACTSEC, a previously validated policy model using data from different population registries.All adults aged 25-84 years living in Denmark in 1991 and 2007.Deaths prevented or postponed (DPP).There were approximately 11,000 fewer CHD deaths in Denmark in 2007 than would be expected if the 1991 mortality rates had persisted. Higher mortality rates were observed in the lowest socioeconomic quintile. The highest absolute reduction in CHD mortality was seen in this group but the highest relative reduction was in the most affluent socioeconomic quintile. Overall, the IMPACTSEC model explained nearly two thirds of the decline in. Improved treatments accounted for approximately 25% with the least relative mortality reduction in the most deprived quintile. Risk factor improvements accounted for approximately 40% of the mortality decrease with similar gains across all socio-economic groups. The 36% gap in explaining all DPPs may reflect inaccurate data or risk factors not quantified in the current model.According to the IMPACTSEC model, the largest contribution to the CHD mortality decline in Denmark from 1991 to 2007 was from improvements in risk factors, with similar gains across all socio-economic groups. However, we found a clear socioeconomic trend for the treatment contribution favouring the most affluent groups.

Land plants are engaged in intricate communities with soil bacteria and fungi indispensable for plant survival and growth. The plant-microbial interactions are largely governed by specific metabolites. We employed a combination of lipid-fingerprinting, enzyme activity assays, high-throughput DNA sequencing and isolation of cultivable microorganisms to uncover the dynamics of the bacterial and fungal community structures in the soil after exposure to isothiocyanates (ITC) obtained from rapeseed glucosinolates. Rapeseed-derived ITCs, including the cyclic, stable goitrin, are secondary metabolites with strong allelopathic affects against other plants, fungi and nematodes, and in addition can represent a health risk for human and animals. However, the effects of ITC application on the different bacterial and fungal organisms in soil are not known in detail. ITCs diminished the diversity of bacteria and fungi. After exposure, only few bacterial taxa of the Gammaproteobacteria, Bacteriodetes and Acidobacteria proliferated while Trichosporon (Zygomycota) dominated the fungal soil community. Many surviving microorganisms in ITC-treated soil where previously shown to harbor plant growth promoting properties. Cultivable fungi and bacteria were isolated from treated soils. A large number of cultivable microbial strains was capable of mobilizing soluble phosphate from insoluble calcium phosphate, and their application to Arabidopsis plants resulted in increased biomass production, thus revealing growth promoting activities. Therefore, inclusion of rapeseed-derived glucosinolates during biofumigation causes losses of microbiota, but also results in enrichment with ITC-tolerant plant microorganisms, a number of which show growth promoting activities, suggesting that Brassicaceae plants can shape soil microbiota community structure favoring bacteria and fungi beneficial for Brassica plants.

Self-tracking devices and apps often measure and provide interpretations of personal data in a rather straightforward way, for instance by visualising the speed and distance of a run or the quality of sleep during night. There is, however, a growing number of devices claiming to support increased wellbeing by extensive data analysis to provide insights and algorithmic advice about unseen and neglected dimensions of our lives, bodies, and experiences. This article engages with two devices of this kind, namely the Moodmetric and the ŌURA which are two recently released ‘smart’ rings with associated smartphone apps that claim to measure emotions and rest, promote happiness and help users to perform better. Focusing on how certain values, visions and ideas are used to frame and explain the potential functionality of these devices, this article approaches the discursive underpinnings of their design as deeply intertwined with the temporalities of late modernity. Empirically, the article is based on a discourse analysis of blog posts, marketing materials and user guides from the ŌURA and Moodmetric companies along with video recordings of the public appearances and sales pitches of company representatives.

A correlation between excess mortality from myocardial infarctions (MI) and schizophrenia has already been established. What remains unclear is whether the initial communication between the treating doctor and the corresponding patient contributes to this excess mortality.The aim of this study is to investigate whether a patient with schizophrenia receives the same offers for examination and treatment following a MI compared to a psychiatric healthy control (PHC).This cohort study includes patients diagnosed with schizophrenia at the time of their first MI (n = 47) in the years between 1995-2015 matched 1:2 to psychiatric healthy MI patients on gender, age and year of first MI. All existing hospital files for the 141 patients were thoroughly reviewed and the number of offered and accepted examinations and treatments were extracted for comparisons between the two groups.In general patients with schizophrenia were less likely to be offered and accept examination and at the same time be offered and accept treatment as compared to PHCs (p

Colorectal cancer (CRC) is one of the most common cancers in the western world. Screening is an efficient method of reducing cancer-related mortality. Molecular biomarkers for cancer in general and CRC in particular have been proposed, and hypermethylated DNA from stool or blood samples are already implemented as biomarkers for CRC screening. We aimed to evaluate the performance of proven hypermethylated DNA promoter regions as plasma based biomarkers for CRC detection.We conducted a cross-sectional case-control study of 193 CRC patients and 102 colonoscopy-verified healthy controls. Using methylation specific polymerase chain reaction, we evaluated 30 DNA promoter regions previously found to be CRC specific. We used multivariable logistic regression with stepwise backwards selection, and subsequent leave-pair-out cross validation, to calculate the optimism corrected area under the receiver operating characteristics curve (AUC) for all stage as well as early stage CRC.None of the individual DNA promoter regions provided an overall sensitivity above 30% at a reasonable specificity. However, seven hypermethylated promoter regions (ALX4, BMP3, NPTX2, RARB, SDC2, SEPT9, and VIM) along with the covariates sex and age yielded an optimism corrected AUC of 0.86 for all stage CRC and 0.85 for early stage CRC. Overall sensitivity for CRC detection was 90.7% at 72.5% specificity using a cut point value of 0.5.Individual hypermethylated DNA promoter regions have limited value as CRC screening markers. However, a panel of seven hypermethylated promoter regions show great promise as a model for CRC detection.

Background: Patients with psoriatic arthritis are at high cardiovascular risk. Marine n-3 polyunsaturated fatty acids (PUFA) may reduce the incidence of cardiovascular disease. The aim of this study was to investigate the effect of marine n-3 PUFA on cardiac autonomic function and vascular function in patients with psoriatic arthritis. Methods: The study was conducted as a randomized, double-blind, placebo-controlled trial, where 145 patients with psoriatic arthritis were supplemented with 3 g of n-3 PUFA or olive oil (control) daily for 24 weeks. Blood pressure, heart rate, HRV, central blood pressure, pulse wave velocity (PWV) and fatty acid composition of granulocytes, were determined. Results: At baseline we found a significant difference in the HRV parameter RR when comparing subjects with the highest vs the lowest fish intake (p = 0.03). After supplementation for 24 weeks there was a trend towards an increase in RR (p= 0.13) and decrease in heart rate (p = 0.12) comparing the n-3 PUFA group with the control group. However, per-protocol analysis (performed on participants who completed the trial with a good compliance) showed significantly increased RR (p = 0.01) and lowered heart rate (p = 0.01) in the n-3 PUFA supplemented patients compared to controls. Blood pressure, PWV and central blood pressure did not change after supplementation with n-3 PUFA. Conclusions: Marine n-3 PUFA increased HRV in patients with psoriatic arthritis which may suggest a protective effect of n-3 PUFA against cardiovascular disease in this population.

Background. In 1998, Denmark introduced the flex job scheme to ensure employment of people with a permanent reduced work capacity. This study investigated the association between select diagnoses and the risk of disability pension among persons eligible for the scheme. Methods. Using the national DREAM database we identified all persons eligible for the flex job scheme from 2001 to 2008. This information piece was linked to the hospital discharge registry. Selected participants were followed for 5 years. Results. From the 72,629 persons identified, our study included 329 patients with rheumatoid arthritis, 10,120 patients with spine disorders, 2179 patients with ischemic heart disease, and 1765 patients with functional disorders. A reduced risk of disability pension was found in the group with rheumatoid arthritis (hazard ratio = 0.69 (0.53–0.90)) compared to the group with spine disorders. No differences were found when comparing ischemic heart disease and functional disorders. Employment during the first 3 months of the flex job scheme increased the degree of employment for all groups. Conclusion. Differences in the risk of disability pension were identified only in patients with rheumatoid arthritis. This study demonstrates the importance of obtaining employment immediately after allocation to the flex job scheme, regardless of diagnosis.

Several studies have engaged in understanding how the internet and online platforms increase political engagement through various forms of online participation and leverage social collective action. This article advances this line of research by exploring how social network sites in general and Facebook in particular are fuelled by algorithms that affect and become entangled with social practices on these sites. The article is empirically grounded in an analysis of 66 self-reflexive diaries on Facebook use and studies algorithmic structures on Facebook by exploring how personalized social feeds affect the experienced relationship between self and others as well as the readiness to share information to a network of peers. In contrast to studies that position online platforms as strengthening participatory political action, this article argues that it is necessary to take into account how algorithmic structures affect interpersonal relationships and the experienced ability to engage in participatory practices.

Abstract Introduction The 1-year PROspective sarilumab (preFILled syringe/pen) multinational, obsErvational (PROFILE) study evaluated the real-world effectiveness and safety of sarilumab in patients with moderate-to-severe rheumatoid arthritis (RA). Methods Safety endpoints included adverse events (AEs) and lab abnormalities. Effectiveness endpoints included the ACR core set. The primary endpoint was the change from baseline in Clinical Disease Activity Index (CDAI). All statistics are descriptive and p values were nominal. Results In total, 595 patients were treated, of whom 223 (37.5%) received sarilumab monotherapy and 372 (62.5%) received combination therapy. Upon initiation of sarilumab, an improvement in the mean (SD) CDAI score was observed at week 24 [11.4 (10.3)] and was maintained through week 52 [10.0 (10.5)], resulting in a mean [SD] reduction of −14.9 (12.7) and −14.4 (12.9), respectively. There were consistent improvements in disease activity that were similar for patients on monotherapy vs. combination therapy. An increase in the proportion of patients achieving remission and low disease activity was reported. By week 52, both groups had improved physical function and quality of life. There were no new safety signals. The proportions of any patients reporting a treatment-emergent adverse event (TEAE) or serious treatment-emergent AE (SAE) was 66.2% and 5.9%, respectively, and were similar between both treatment groups. Overall, 15.6% of patients discontinued sarilumab treatment due to TEAEs. The most commonly reported TEAE of interest was neutropenia (14.1%). Conclusions In this 1-year, observational real-world study, sarilumab therapy resulted in improved clinical outcomes. The safety profile was consistent with that observed in sarilumab randomized clinical trials. This study was entered on the German website (Paul Ehrlich Institute) on January 11, 2018, with NIS No.: 423.