The Hand that Rocks the Cradle: Maternal Gender Subversion in American Suffrage Drama

This thesis aims to shed light on the maternal role and its use in subverting feminine gender association. The maternal has always been an important facet in the construction of gender, specifically that of the feminine. By viewing three pieces of American suffrage drama: Ariana Curtis's The Spirit of '76, or The Coming Woman, a Prophetic Drama (1868), Alice Ives's A Very New Woman (1896) and Alice Thompson's A Suffragette Baby (1912), through Judith Butler's performative gender lens, we learn new things about the maternal. Most importantly, we ascertain that the maternal is an entity separate from the feminine gender, that it can be moved and that it can be reapplied to designate non-feminine bodies as maternal. This knowledge has the potential to destabilize gender construction by helping to fragment the feminine, thereby diminishing the power associated with gender as a comprehensive unit

Ultra-Sounding Maternal Subjectivity: A Feminist Reclamation of Pregnancy and Childbirth on Stage

Maternal subjectivity, as it is formed through pregnancy and birth experiences, is avoided in theatrical depiction. While particular limitations demand that the depiction of gestation be shortened in plays, what has resulted has been an over-correction that is detrimental to women, claiming that exclusively female experiences are unimportant. Theatrical conventions, such as pregnant belly costumes, bundled blankets and baby-crying sound effects, are the main culprits of this phenomena. These conventions reduce the experience of pregnancy and birth to visual or auditory cues for the audience that are communally understood in a singular way and separate it away from the woman’s own experience and identity development. Another contributor to this problem is the privileging of other characters’ perspectives over that of the gestating/birthing/maternal woman. This practice devalues the woman and reinforces damaging notions of uncontrollable hysteria that have been historically linked to the female, gestating body. I propose looking at a larger picture of the pregnant/birthing woman that encompasses more of her experience. I divide gestation into five phases: perpetually-potentially pregnant, invisibly pregnant, visibly pregnant, birthing and immediate postpartum. This extension allows for a closer look at how these experiences affect the woman. I look at six plays as case studies to see how they handle the pregnant/birthing/maternal women in their scripts. I conclude that there has been much ground covered with respect to women’s agency and autonomy in drama, but these gains have contributed an overshadowing of an essential experience for many women. Playwrights treat pregnancy and childbirth as inconsequential with respect to how they affect a woman’s identity and allowing this to continue has the potential to hinder feminist progress writ large

The culinary coding of gender construction : simplicity rhetoric in cookbooks from the Little Blue Book Series

This article examines the use of rhetoric that emphasises simplicity with reference to home food preparation while also considering different possible motivations behind this use in order to bring the movement and juxtaposition of these categories to light. The Little Blue Book Series focused on improving peoples’ lives with easy-to-follow directions. Their mission enabled the creation of an abundance of simplicity rhetoric used in cooking instruction that contributed to the construction of gender for many middle-class, white, American women. Though the Haldeman-Julius Publishing Company printed these types of booklets for over sixty years, I focus on the years of its greatest popularity, from about 1925 to 1940. The three books covered here were chosen because of their specific use of language within their cooking instruction. Specifically, I look at Gaylord Du Bois’s Simple Recipes for Home Cooking (No. 997, 1927), Albert Hohl’s The Simplified Cook-Book: Hints on Cookery (No. 1756, 1938), and Gloria Goddard’s The Perfect Pocket Cookbook (No. 1360, 1929). I also use other cookbooks of the era to further delimit the historical context as well as contemporary scholarship on cooking to assist in my analysis. I situate my study at the intersection of gender, food, and rhetoric studies.peer-reviewe

An Efficient Algorithm For Simulating Fracture Using Large Fuse Networks

The high computational cost involved in modeling of the progressive fracture simulations using large discrete lattice networks stems from the requirement to solve {\it a new large set of linear equations} every time a new lattice bond is broken. To address this problem, we propose an algorithm that combines the multiple-rank sparse Cholesky downdating algorithm with the rank-p inverse updating algorithm based on the Sherman-Morrison-Woodbury formula for the simulation of progressive fracture in disordered quasi-brittle materials using discrete lattice networks. Using the present algorithm, the computational complexity of solving the new set of linear equations after breaking a bond reduces to the same order as that of a simple {\it backsolve} (forward elimination and backward substitution) {\it using the already LU factored matrix}. That is, the computational cost is $O(nnz({\bf L}))$, where $nnz({\bf L})$ denotes the number of non-zeros of the Cholesky factorization ${\bf L}$ of the stiffness matrix ${\bf A}$. This algorithm using the direct sparse solver is faster than the Fourier accelerated preconditioned conjugate gradient (PCG) iterative solvers, and eliminates the {\it critical slowing down} associated with the iterative solvers that is especially severe close to the critical points. Numerical results using random resistor networks substantiate the efficiency of the present algorithm.Comment: 15 pages including 1 figure. On page pp11407 of the original paper (J. Phys. A: Math. Gen. 36 (2003) 11403-11412), Eqs. 11 and 12 were misprinted that went unnoticed during the proof reading stag

Reproducible gene targeting in recalcitrant Escherichia coli isolates

<p>Abstract</p> <p>Background</p> <p>A number of allele replacement methods can be used to mutate bacterial genes. For instance, the Red recombinase system of phage Lambda has been used very efficiently to inactivate chromosomal genes in <it>E. coli </it>K-12, through recombination between regions of homology. However, this method does not work reproducibly in some clinical <it>E. coli </it>isolates.</p> <p>Findings</p> <p>The procedure was modified by using longer homologous regions (85 bp and 500-600 bp), to inactivate genes in the uropathogenic <it>E. coli </it>strain UTI89. An <it>lrhA </it>regulator mutant, and deletions of the <it>lac </it>operon as well as the complete <it>type 1 </it>fimbrial gene cluster, were obtained reproducibly. The modified method is also functional in other recalcitrant <it>E. coli</it>, like the avian pathogenic <it>E. coli </it>strain APEC1. The <it>lrhA </it>regulator and <it>lac </it>operon deletion mutants of APEC1 were successfully constructed in the same way as the UTI89 mutants. In other avian pathogenic <it>E. coli </it>strains (APEC3E, APEC11A and APEC16A) it was very difficult or impossible to construct these mutants, with the original Red recombinase-based method, with a Red recombinase-based method using longer (85 bp) homologous regions or with our modified protocol, using 500 - 600 bp homologous regions.</p> <p>Conclusions</p> <p>The method using 500-600 bp homologous regions can be used reliably in some clinical isolates, to delete single genes or entire operons by homologous recombination. However, it does not invariably show a greater efficiency in obtaining mutants, when compared to the original Red-mediated gene targeting method or to the gene targeting method with 85 bp homologous regions. Therefore the length of the homology regions is not the only limiting factor for the construction of mutants in these recalcitrant strains.</p

Radiotelemetry monitored measurements of the effects of medetomidine-midazolam-fentanyl, isoflurane or ketamine-xylazine anaesthesia on physiological parameters in guinea pigs

Anaesthesia in guinea pigs (GPs) has often been described as difficult and risky. Therefore, the included publications invested the effect of the mostly used anaesthesias MMF (medetomidine-midazolam-fentanyl), isoflurane (Iso) and ketamine-xylazine (KX) on physiological parameters in GPs. Throughout the anaesthesia, the GPs’ cardiovascular parameters were monitored, using abdominally implanted radiotelemetry devices to obtain optimal data quality. The surgical approach used for the implantation of the radiotelemetry transmitter is presented in detail in the first publication. For surgery, the GPs were anaesthetised with MMF (medetomi-dine-midazolam-fentanyl) and they were antagonised with AFN (atipamezole-flumazenil-nalxone) at the end of the surgery. For pain medication, the GPs were started on meloxicam (0.4 mg/kg) and metamizole (80 mg/kg) 30 min before the surgery. Metamizole was continued for 24 h after surgery and meloxicam for 2 more days. During the implantation, they were additionally covered with the fentanyl component in MMF. Prior to the surgery, enrofloxacin (10 mg/kg) was applied for antibiotic coverage which was continued for 2 more days. Using the implanted system, arterial blood pressure (BP), heart rate (HR) and core body temperature (BT) were measured throughout the first 24 h after the end of the implantation. The implantation approach led to the highest long-term survival rate reported to date, with 13 of 16 GPs (81 %) surviving. The GPs lost body weight (BW) until 2 d after surgery (-11.9 %, -53.6 g) but steadily increased their weight thereafter. The GPs had returned to physiological values in BP and BT at 8 h after abdominal surgery and at 24 h regarding HR. As GPs are stress-prone, recommendations for stress reduced handling were given for before, during and after the implantation. The findings on the effects of the implantation can be used as a model for other abdominal operations in the GP. The second publication described the investigation of the effects of one-time Iso, MMF and KX anaesthesia on the physiological parameters using the 13 implanted GPs. Each animal was anesthetised once with MMF, Iso and KX at an interval of 7 d. The entire anaesthesia pass was recorded radiotelemetrically and supplemented by manual measurements of respiratory rate (ReR), reflexes and blood glucose (BG). One anaesthesia pass included 120 min acclimatization time, of which the last 15 min were averaged as individual baseline values. The GPs were then premedicated; with Iso with atropine and with MMF and KX with sodium chloride as placebo. Ten minutes later, anaesthesia was initiated, for Iso anaesthesia using a pre-filled whole body chamber and for MMF and KX with intramuscular injections into the hind limbs. Anaesthesia was discontinued after 40 min by Iso supply stop, AFN antagonisation for MMF or partial antagonisation with atipamezole for KX anaesthesia. The MAP, HR, BT were measured continuously until at least 240 min after anaesthesia induction. Respiratory rate (ReR) was measured until at least 55 min and reflexes were tested until the GPs showed a positive righting reflex again. BG values were measured at 7.5, 20 and 40 min during anaesthesia. With Iso use, all GPs reached a surgical tolerance, 11 did so with MMF anaesthesia and only 7 reached an operable state with KX. The induction, non-surgical tolerance and surgical tolerance phase durations did not differ considerably between the 3 anaesthetics. Following MMF and Iso there were short wake-up times (7.6 & 12.2 min), whereas it required 59.7 min until the GPs regained their RR after KX. MMF anaesthesia led to a marked transient MAP decrease after antagonisation, otherwise the MAP and the HR were only mildly altered. Iso exposure led to a marked hypotension during anaesthesia maintenance (approx. 20 mmHg) and the HR was only mildly increased at the beginning of the anaesthesia. KX caused mild deviations from the normal physiology for MAP and HR during maintenance. However, after partial antagonisation, the MAP dropped and the GPs recovered only slowly. The HR was also reduced and increased only gradually during the wake-up following KX anaesthesia. All anaesthetics induced hypothermia, but the animals lost the most BT with Iso anaesthesia. Immediately after the end of the MMF and Iso anaesthesia, the GPs were able to quickly lift their BT back to the starting level through shivering. After KX anaesthesia only 3 of the 7 GPs had returned to 38.8°C after 5 h, the other 4 still had not reached pre-anaesthetic BT values after 8 h. Respiratory depression occurred with all 3 anaesthetics, with KX leading to a moderate (-52%) and Iso to a severe (-71%) hypoventilation. There was also a strong irritation of the mucous membranes of the respiratory tract through the respiratory gas. Subsequent mucosal secretion could only be alleviated by atropine pre-medication in the short term. BG increases were observed during KX (moderate) and strongly during MMF anaesthesia. The reflex responses varied considerably between the anaesthetics. They were strong and quick during MMF anaesthesia and slightly less so with KX use. Iso exposure led to weak and slow reflex responses. Overall, MMF was determined to be the anaesthesia of choice; Iso can only be advised for short and non-painful procedures and we advise against the use of KX anaesthesia in GPs. After investigating the effects of single anaesthesia with Iso, MMF and KX, the third paper de-scribed the impact of repeated MMF and Iso anaesthesia. KX was not tested for anaesthesia repetition because of its highly unfavourable effects in the recovery phase. Twelve instrumented MS were anesthetised in 2 anaesthesia sets, 6 times over 3 weeks with either only Iso or only MMF. Each anaesthesia repetition was performed as described for the single anaesthesia. All GPs reached a surgical tolerance and this could be maintained for the desired 40 min. Overall, the anaesthetic profiles of MMF and Iso did not change greatly with anaesthesia repetition. During Iso exposure, the repeated atropine premedication caused the HR to increase, and this increase remained longer with progressing repetitions. During MMF the wake-up phase short-ened from the 1st to the 2nd repetition and the MAP and the HR decreased from the first to all following anaesthesias. During the MMF maintenance, there was a large individual variation in the BP between the GPs, but the single animal always exhibited similar MAP values during all of the repetitions. At 40 min of the MMF anaesthesia, the BG had increased particularly strongly in those anaesthesias that were performed with an interval of 2 d. The BT decrease and the BW increase were not altered. Both anaesthetics can therefore be used repeatedly in the GP with very little change in the anaesthesia profile compared to the single anaesthesias. The GPs developed increasingly stronger defensive reactions which were particularly pronounced with Iso. They reduced the reliability with which the injections of MMF and atropine could be performed and with that the induction of anaesthesia. Although repeated Iso anaesthesia led to lesser repetition-related effects, the highly disadvantageous effects of hypotension, mucous production and hypoventilation with Iso anaesthesia remained and were further worsened by the strong defensive reactions. MMF led to a much more beneficial anaesthesia with the only drawback of altering the BG and the occurring hypothermia. In conclusion, MMF is superior for both single and repeated anaesthesia use in the GP. Iso is only preferable to MMF, if multiple anaesthesias need to be performed on the same day.Die Anästhesie an Meerschweinchen (MS) wurde schon oft als schwierig und risikoreich be-schrieben. Mit diesem Hintergrund wurden die drei häufigsten Narkosemittel, Medetomidin-Midazolam-Fentanyl (MMF), Isofluran (Iso) und Ketamin-Xylazin (KX), hinsichtlich ihres Einflusses auf die physiologischen Parameter im MS untersucht. Die Überwachung vor, während und nach den Anästhesien wurde durch einen abdominal implantierten Radiotelemetriesender durchgeführt. In der ersten Publikation wurde die Implantation des Telemetriesenders detailliert dargestellt. Für den Eingriff wurden die MS mit MMF anästhesiert und die Narkose wurde am Ende des Eingriffes mit AFN (Atipamezol- Flumazenil-Naloxon) wieder aufgehoben. Die Analgesie bestand aus Meloxicam (0,4 mg/kg) und Metamizol (80 mg/kg), womit 30 Minuten vor dem Start der Operation begonnen wurde. Während der Anästhesie wurde die Analgesie zusätzlich über die Fentanyl Komponente des MMFs erhalten. Nach der Implantation wurde Metamizol für 24 Stunden und Meloxicam für 48 h fortgesetzt. Zur antibiotischen Versorgung erhielten die MS Enrofloxacin (10 mg/kg) vor dem Beginn der Operation und in den zwei darauffolgenden Tagen. Unter Verwendung des implantierten Senders wurden der arterielle Blutdruck (BD), die Herzfrequenz (HF) und die Kernkörpertemperatur (KT) in den ersten 24 h nach dem Ende der Implantation gemessen. Die durchgeführte Implantationsherangehensweise führte zu der bisher höchsten publizierten Langzeitüberlebensrate mit 13 von 16 Tieren (81%). Bis 2 Tage nach der Operation verloren die Tiere an Körpergewicht (-11,9 %, -53,6 g). Danach stieg ihr Gewicht jedoch stetig wieder an. Die MS waren nach 8 h nach ihrer abdominalen Operation zu physiologischen Werten in Blutdruck und Körperkerntemperatur und nach 24 h zu normalen HF zurückgekehrt. Aufgrund der hohen Stressanfälligkeit von MS, wurden Empfehlungen für stressarmes Handling, für vor, während und nach der Implantation gegeben. Die Erkenntnisse über die Auswirkungen der Implantation können modelhaft auf andere Bauchoperationen im MS angewendet werden. Die zweite Veröffentlichung beschrieb die Untersuchung der Wirkungen von einmaligen Iso, MMF und KX Anästhesien auf die physiologischen Parameter unter Verwendung der 13 implan-tierten MS. Jedes Tier wurde einmalig mit MMF, Iso und KX im Abstand von 7 d anästhesiert. Der gesamte Anästhesiedurchgang wurde radiotelemetrisch aufgezeichnet und durch manuelle Erhebungen für Atemfrequenz (AF), Reflexe und Blutglukose (BG) ergänzt. Ein Anästhesiedurch-gang beinhaltete 120 min Akklimatisierungszeit, wovon die letzten 15 min als individuelle Baselinewerte gemittelt wurden. Danach wurden die MS prämediziert; bei Iso mit Atropin und bei MMF und KX mit Natriumchlorid als Placebo. Zehn min später wurde die Anästhesie eingeleitet mit einer vorgefluteten Ganzkörperkammer für die Iso Anästhesie und für MMF und KX mit intramuskulären Injektionen in die Hintergliedmaßen. Die Anästhesie wurde für nach 40 min aufgehoben durch Iso-zufuhrstopp, AFN Antagonisierung oder Teilantagonisierung mit Atipamezol. Der BD, die HF, und die KT wurden kontinuierlich bis mindestens 240 min nach Anästhesieeinleitung gemessen. Die AF wurde bis mindestens 55 min gemessen, und die Reflexe wurden bis zum Erreichen eines positiven Stellreflexes getestet. Bei 7,5, 20 und 40 min während der Anästhesie wurden BG Werte erhoben. Mit der Anwendung von Iso erreichten alle MS eine chirurgische Toleranz, mit der MMF-Anästhesie waren es 11 MS und nur 7 erreichten einen operablen Zustand mit KX. Die Induktion, nicht-chirurgische Toleranz und chirurgische Toleranzphasendauer unterschieden sich nicht erheblich zwischen den 3 Anästhetika. Auf die Narkosen mit MMF und Iso folgten kurze Weckzeiten (7,6 & 12,2 min), während es 59,7 min benötigte, bis die MS ihren RR nach KX wiedererlangten. Die MMF-Anästhesie führte zu einer kurzen, deutlichen BD-Abnahme nach Antagonisierung, ansonsten wurden der BD und der HF nur geringfügig verändert. Die Iso-Exposition führte zu einer ausgeprägten Hypotonie während der Anästhesieerhaltung (ca. 20 mmHg) und die HF war zu Beginn der Anästhesie nur leicht erhöht. KX verursachte nur milde Abweichungen von der normalen Physiologie für BD und HF während der Anästhesieerhaltung. Nach der Teilantagonisierung fiel der BD die HF und die KT jedoch ab und die MS erholten sich nur langsam. Alle Anästhetika induzierten eine Hypothermie, aber unter der Iso Narkose verloren die MS am schnellsten und am meisten Körpertemperatur. Direkt nach dem Ende der MMF- und Iso-Narkose konnten sie ihre KT über Kältezittern schnell wieder auf das Ausgangslevel heben. Nach der KX-Anästhesie waren jedoch nur 3 der 7 GPs auf 38,8 ° C KT zurückgekehrt, die anderen 4 hatten auch nach 8 h noch nicht wieder ihre Ausgangskörperkerntemperatur erreicht. Eine Atemdepression trat bei allen 3 Narkosemitteln auf, am ausgeprägtesten jedoch unter der Iso-Narkose (-71%). Dort trat zusätzlich eine starke Reizung der Schleimhäute der Atemwege durch das Atemgas auf. Die nachfolgende Schleimsekretion konnte durch die Atropinprämedikation nur kurzfristig gelindert werden. Der BG-Spiegel stieg während der Anästhesie mit KX (mäßig) und während der MMF-Anästhesie stark an. Die Reflexantworten variierten erheblich zwischen den Anästhetika. Sie waren stark und schnell während der MMF Anästhesie und etwas weniger deutlich ausgeprägt unter der KX-Anwendung. Die Iso-Exposition führte hingegen zu schwachen und langsamen Reflexantworten. Insgesamt ist MMF die Anästhesie der Wahl beim MS; Iso sollte nur für kurze und nicht schmerzhafte Verfahren beraten werden und wir empfehlen die Verwendung von KX Anästhesie bei GPs. Nach der Untersuchung der Einzelanästhesieffekte mit Iso, MMF und KX, beschrieb die dritte Publikation die Auswirkungen der wiederholten MMF- und Iso-Anästhesie. Aufgrund der deutli-chen Nachtteile der KX-Narkose in der Aufwachphase wurde KX von der Wiederholungsstudie ausgeschlossen. Zwölf instrumentierte MS wurden in 2 Anästhesiesets jeweils 6 mal über 3 Wo-chen mit entweder nur Iso oder nur MMF anästhesiert. Der Aufbau der einzelnen Anästhesie-durchgänge war derselbe wie bei in Einzelanästhesien beschrieben. Alle GPs erreichten eine chirurgische Toleranz, und diese konnte für die gewünschten 40 min aufrechterhalten werden. Insgesamt änderten sich die Anästhesieprofile von MMF und Iso nur sehr gering im Verlauf der Anästhesiewiederholung. Durch die wiederholte Atropinprämedikation nahm die HF zu und dieser Anstieg blieb mit fortschreitenden Wiederholungen immer länger bestehen. Bei der MMF Anästhesie verkürzte sich die Aufwachzeit vor allem von der 1. auf die 2. Wiederholung. Der BP und die HF nahmen nach der ersten Wiederholung für die nachfolgenden Anästhesien ab. Während der MMF-Anästhesieerhaltung zeigten die MS große individuelle Variationen im BD. Jedes einzelne Tier blieb jedoch während allen Wiederholungen auf seinem eigenen Niveau. Die BG war bei den MMF-Anästhesien zwischen denen nur 2 Tage lagen 40 min nach der Anästhesieeinleitung besonders hoch. Die KT-Abnahme trat sowohl bei MMF, als auch bei Iso während der Anästhesie auf und die Körpergewichtsentwicklung veränderte sich durch die Wiederholungen nicht. Sowohl Iso als auch MMF können nach diesen Ergebnissen daher wiederholt in MS eingesetzt werden. Trotzdem entwickelten die MS zunehmend stärkere Abwehrreaktionen gegen die Anäs-thesieeinleitung, die bei Iso besonders ausgeprägt waren. Sie reduzierten die Zuverlässigkeit, mit der die Injektionen von MMF und Atropin durchgeführt werden konnten und damit die Induktion der Anästhesie. Die Iso-Anästhesie führte zwar zu geringeren Wiederholungswirkungen im Vergleich zu MMF, das Anästhesieprofil mit der starken Atemdepression und Schleimproduktion und der starken Hypotension bestand jedoch weiterhin. Insgesamt sind die Effekte der Wiederholungen bei der MMF Anästhesie weitgehend vernachlässigbar und das Anästhesieprofil ist wesentlich vorteilhafter für die MS. Daher ist MMF für die einfache und wiederholte Anästhesie im MS das Anästhetikum der Wahl, es sei denn am selben Tag müssen mehrere Anästhesien durchgeführt werden müssen. In dem Fall ist Iso vorzuziehen

Self-Organizing Time Map: An Abstraction of Temporal Multivariate Patterns

This paper adopts and adapts Kohonen's standard Self-Organizing Map (SOM) for exploratory temporal structure analysis. The Self-Organizing Time Map (SOTM) implements SOM-type learning to one-dimensional arrays for individual time units, preserves the orientation with short-term memory and arranges the arrays in an ascending order of time. The two-dimensional representation of the SOTM attempts thus twofold topology preservation, where the horizontal direction preserves time topology and the vertical direction data topology. This enables discovering the occurrence and exploring the properties of temporal structural changes in data. For representing qualities and properties of SOTMs, we adapt measures and visualizations from the standard SOM paradigm, as well as introduce a measure of temporal structural changes. The functioning of the SOTM, and its visualizations and quality and property measures, are illustrated on artificial toy data. The usefulness of the SOTM in a real-world setting is shown on poverty, welfare and development indicators

Applications of Machine Learning to Flight Dynamics Operations

No abstract availabl

The Binge Eating Genetics Initiative (BEGIN): Study protocol

Background: The Binge Eating Genetics Initiative (BEGIN) is a multipronged investigation examining the interplay of genomic, gut microbiota, and behavioral factors in bulimia nervosa and binge-eating disorder. Methods: 1000 individuals who meet current diagnostic criteria for bulimia nervosa or binge-eating disorder are being recruited to collect saliva samples for genotyping, fecal sampling for microbiota characterization, and recording of 30 days of passive data and behavioral phenotyping related to eating disorders using the app Recovery Record adapted for the Apple Watch. Discussion: BEGIN examines the interplay of genomic, gut microbiota, and behavioral factors to explore etiology and develop predictors of risk, course of illness, and response to treatment in bulimia nervosa and binge-eating disorder. We will optimize the richness and longitudinal structure of deep passive and active phenotypic data to lay the foundation for a personalized precision medicine approach enabling just-in-time interventions that will allow individuals to disrupt eating disorder behaviors in real time before they occur. Trial registration: The ClinicalTrials.gov identifier is NCT04162574. November 14, 2019, Retrospectively Registered