Depue & Collins's (D&C's) work relies on extrapolation from data obtained through studies in experimental animals, and needs support from studies of the role of dopamine (DA) neurotransmission in human behaviour. Here we review evidence from two sources: (1) studies of patients with Parkinson's disease and (2) positron emission tomography (PET) studies of DA neurotransmission, which we believe lend support to Depue & Collins's theory, and which can potentially form the basis for a true neurochemistry of personality.

The astonishing efficiency and accuracy of DNA replication has long suggested that refined rules enforce a single highly reproducible sequence of molecular events during the process. This view was solidified by early demonstrations that DNA unwinding and synthesis are coupled within a stable molecular factory, known as the replisome, which consists of conserved components that each play unique and complementary roles. However, recent single-molecule observations of replisome dynamics have begun to challenge this view, revealing that replication may not be defined (...) by a uniform sequence of events. Instead, multiple exchange pathways, pauses, and DNA loop types appear to dominate replisome function. These observations suggest we must rethink our fundamental assumptions and acknowledge that each replication cycle may involve sampling of alternative, sometimes parallel, pathways. Here, we review our current mechanistic understanding of DNA replication while highlighting findings that exemplify multi-pathway aspects of replisome function and considering the broader implications. Recent single-molecule studies have revealed that replisome function is dominated by stochastic sampling of multiple molecular pathways. In the context of these new findings, we re-examine the foundational assumptions and seminal experiments that have guided our understanding of replication mechanism and reconcile several long-debated coordination models. (shrink)

This work is a revision of the False Dilemma Fallacy (FDF). The formalized model (FM)of this fallacy has as its centerpiece a valid disjunctive syllogism, but the disjunctive premise is presumed to be false, thus making the argument unsound. Our revised model (FM2.0) focuses on the formal structure by comparing the given vs. the real argument, which is unsound because of its invalidity. This approach we believe is more pedagogically useful and a better explanation of the fallacious nature of the (...) FDF. It extends the identity of “formal fallacy” to the FDF. The abstract is formatted in two columns. The English abstract goes on this side. (shrink)

Religion -- Metaphilosophy -- Marxism -- Global justice -- Nationalism.

In lieu of an abstract, here is a brief excerpt of the content:Two Stories in One: Literature as a Hidden Door to the History of Seventeenth-Century FranceChristian Jouhaud (bio)Translated by Cynthia J. Koepp (bio)I would like to take you into the history of seventeenth-century France through a narrow door—a door that is not only narrow but hidden. Why should we struggle to squeeze through this passage? Well, there are at least two reasons. First, it is an attempt to experience (...) a disorienting perspective on a landscape that we believe we already know completely; and second, the narrowness of the path underlines its particularity and in that way elicits a comparison with other paths elsewhere. This narrow passage is a text, perhaps an insignificant one, written by a seventeenth-century author. After making a few observations concerning its mechanics, I will use this text as a model to interpret something else, to understand it as something that stimulates thinking about historiographical hypotheses: as a convenient tool to shake up the political history of seventeenth-century France. In other words, I propose to utilize literature as a hidden door in order to enter the arena of political history, where we usually do not find any door at all.Deux histoires en une, or Two Stories in One, is a brief text by Jean-Louis Guez de Balzac, a work of uncertain status, published among dozens of other pieces in a collection known by two titles: Moral Treatises and Conversations. Guez de Balzac, who lived between 1595 and 1654, does not appear on the short list of the most celebrated writers of seventeenth-century France: Molière, Racine, Corneille, La Fontaine, Sévigné, Bossuet. At the time, however, he occupied center stage in French literary life. He was perhaps the first author recognized as a grand écrivain; he was widely admired, celebrated, criticized. At the center of protracted literary debates, Guez de Balzac exercised an immense critical authority in the world of belles lettres.Since I first began working on the question of the birth of literature as a specific social space in seventeenth-century France, I have not stopped reading and rereading Balzac’s Two Stories in One. This text resists interpretation—even comprehension. It gives the reader the feeling—to be honest, an exasperating feeling—of extraordinary richness and also of an extraordinary capacity to steal away from view. The importance of this text for the comprehension of something other than itself, however, has become clear to me. This leapt out at me, by chance, when I was reading it for the nth time—at nearly the same time that I was rereading several pages of Marcel Proust. Not that the author of À la recherche du temps perdu had any connection at all to Guez de Balzac. Rather, it was Proust’s evoking, in his way, two stories in one—or rather one story in two parts—that for me rendered suddenly palpable something of the force of Balzac’s text.At the beginning of À l’ombre des jeunes filles en fleurs, Proust meditates on the story of Swann before and after his marriage. He emphasizes our incapacity to think of two successive states in the history of our life at the same time: for example, that of a jealous lover and that of an appeased husband. If one succeeds in thinking both things at once, the two moments then cease to appear distinct to us, and are mixed up one in the other. If the [End Page 92] mind wants to distinguish them, it loses the ability to think them both at once. I would like to propose an hypothesis that the import of Balzac’s Two Stories in One, contrary to Proust, is an attempt to open up to speculation an improbable space, a space imperceptible to sensory experience. This space lies at the interstice of “both at once” and “separately.” Thus Balzac attempts to escape the dilemma of superimposition (that is to say, fusion) or of succession (that is, separation). He attempts to subvert the elementary rule of logic that states that “a” is either different from “b” or is the same as “b.”What is striking when one first reads Two Stories in... (shrink)

In order to improve our understanding of the components that reflect functionally important processes during reward anticipation and consumption, we used principle components analyses (PCA) to separate and quantify averaged ERP data obtained from each stage of a modified monetary incentive delay (MID) task. Although a small number of recent ERP studies have reported that reward and loss cues potentiate ERPs during anticipation, action preparation, and consummatory stages of reward processing, these findings are inconsistent due to temporal and spatial overlap (...) between the relevant electrophysiological components. Our results show three components following cue presentation are sensitive to incentive cues (N1, P3a, P3b). In contrast to previous research, reward‐related enhancement occurred only in the P3b, with earlier components more sensitive to break‐even and loss cues. During feedback anticipation, we observed a lateralized centroparietal negativity that was sensitive to response hand but not cue type. We also show that use of PCA on ERPs reflecting reward consumption successfully separates the reward positivity from the independently modulated feedback‐P3. Last, we observe for the first time a new reward consumption component: a late negativity distributed over the left frontal pole. This component appears to be sensitive to response hand, especially in the context of monetary gain. These results illustrate that the time course and sensitivities of electrophysiological activity that follows incentive cues do not follow a simple heuristic in which reward incentive cues produce enhanced activity at all stages and substages. (shrink)

With the outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), global researchers were confronted with major challenges. The German National Pandemic Cohort Network (NAPKON) was launched in fall 2020 to effectively leverage resources and bundle research activities in the fight against the coronavirus disease 2019 (COVID-19) pandemic. We analyzed the setup phase of NAPKON as an example for multicenter studies in Germany, highlighting challenges and optimization potential in connecting 59 university and nonuniversity study sites. We examined the ethics application (...) process of 121 ethics submissions considering durations, annotations, and outcomes. Study site activation and recruitment processes were investigated and related to the incidence of SARS-CoV-2 infections. For all initial ethics applications, the median time to a positive ethics vote was less than two weeks and 30 of these study sites (65%) joined NAPKON within less than three weeks each. Electronic instead of postal ethics submission (9.5 days (Q1: 5.75, Q3: 17) vs. 14 days (Q1: 11, Q3: 26), p value = 0.01) and adoption of the primary ethics vote significantly accelerated the ethics application process. Each study center enrolled a median of 37 patients during the 14-month observation period, with large differences depending on the health sector. We found a positive correlation between recruitment performance and COVID-19 incidence as well as hospitalization incidence. Our analysis highlighted the challenges and opportunities of the federated system in Germany. Digital ethics application tools, adoption of a primary ethics vote and standardized formal requirements lead to harmonized and thus faster study initiation processes during a pandemic. (shrink)

Die Posttraumatische Belastungsstörung (PTBS) ist ein schwerwiegendes psychisches Krankheitsbild, das Betroffene nach dem Erleben traumatisierender Situationen entwickeln. Im Zusammenhang mit den Auslandseinsätzen der Bundeswehr ist die PTBS bei Soldaten in den letzten Jahren verstärkt in den Fokus der deutschen Öffentlichkeit gerückt. Auch zivile Traumata bergen ein großes PTBS-Risiko. Seit einigen Jahren werden Methoden zur medikamentösen Prävention der PTBS erforscht. Die beiden wichtigsten Ansätze, die Prävention mit zentralnervös wirkenden Betablockern und Glukokortikoiden, basieren auf der Idee, durch den Eingriff in neuroendokrine Stressachsen (...) Einfluss auf die Art und Weise zu nehmen, in der die Erinnerung im Gedächtnis konsolidiert wird. Durch eine Entemotionalisierung und Abschwächung entsprechender Gedächtnisspuren soll das spätere Auftreten einer PTBS verhindert werden. Beide Ansätze zeigen in Pilotstudien vielversprechende Ergebnisse. Angesichts der herausragenden Bedeutung des Gedächtnisses für Individuum und Gesellschaft sollten Ansätze zur medikamentösen Gedächtnismodifikation (MGM) unter neuroethischen Gesichtspunkten diskutiert und bewertet werden. Der Text beleuchtet die MGM zur PTBS-Prävention entlang von fünf Problemachsen: 1) der Einflussnahme von MGM auf den Prozess der normalen psychischen Verarbeitung traumatischer Erlebnisse, 2) der Gefahr einer Entkopplung von Erinnerung und Realität, 3) der Bedeutung von emotionaler Erinnerung für die Moral, 4) der sozialen, juristischen und historischen Relevanz einer wahrhaftigen Erinnerungskultur und 5) der potenziellen Förderung eines gesellschaftlichen Medikalisierungsprozesses. Trotz ernsthaft zu diskutierender ethischer Bedenken ist – vor dem Hintergrund der Schwere des Krankheitsbilds – aus unserer Sicht eine MGM zur PTBS-Prävention grundsätzlich begrüßenswert, sollte jedoch derzeit nur im Rahmen klinischer Studien erfolgen. Hierfür stellen wir acht forschungsethische Aspekte zur Diskussion, die bei solchen Studien zu berücksichtigen sind. (shrink)

Hip implants have provided life-changing treatment, reducing pain and improving the mobility and independence of patients. Success has encouraged manufacturers to innovate and amend designs, engendering patient hopes in these devices. However, failures of medical implants do occur. The failure rate of the Articular Surface Replacement metal-on-metal hip system, implanted almost 100,000 times world-wide, has re-opened debate about appropriate and timely implant governance. As commercial interests, patient hopes, and devices' governance converge in a socio-technical crisis, we analyse the responses of (...) relevant governance stakeholders in the United Kingdom between 2007 and 2014. We argue that there has been a systemic failure of the governance system entrusted with the safety of patients fitted with medical implants. Commercial considerations of medical implants and the status quo of medical implant governance have been given priority over patient safety despite the availability of significant failure data in an example of uncertainty about what constitutes appropriate precautionary action. (shrink)

In the target article, Bowers et al. dispute deep artificial neural network (ANN) models as the currently leading models of human vision without producing alternatives. They eschew the use of public benchmarking platforms to compare vision models with the brain and behavior, and they advocate for a fragmented, phenomenon-specific modeling approach. These are unconstructive to scientific progress. We outline how the Brain-Score community is moving forward to add new model-to-human comparisons to its community-transparent suite of benchmarks.

Autobiographical–episodic memory is the conjunction of subjective time, autonoetic consciousness and the experiencing self. Understanding the neural correlates of autobiographical–episodic memory might therefore be essential for shedding light on the neurobiology underlying the experience of being an autonoetic self. In this contribution we illustrate the intimate relationship between autobiographical–episodic memory and self by reviewing the clinical and neuropsychological features and brain functional imaging correlates of psychogenic amnesia – a condition that is usually characterized by severely impaired retrograde memory functioning, in (...) absence of structural brain damage as detected by standard imaging. We demonstrate that in this disorder the autobiographical–episodic memory deficits do not exist in isolation, but occur with impairments of the autonoetic self-consciousness, emotional processing, and theory of mind or executive functions. Furthermore functional and metabolic brain alterations involving regions that are agreed upon to exert crucial roles in memory processes were frequently found to accompany the psychogenic memory “loss”. (shrink)

Heterogeneity within MDD has hampered identification of biological markers (e.g., intermediate phenotypes, IPs) that might increase risk for the disorder or reflect closer links to the genes underlying the disease process. The newer characterizations of dimensions of MDD within Research Domain Criteria (RDoC) domains may align well with the goal of defining IPs. We compare a sample of 25 individuals with MDD compared to 29 age and education matched controls in multimodal assessment. The multimodal RDoC assessment included the primary IP (...) biomarker, positron emission tomography (PET) with a selective radiotracer for 5-HT1A ([11C]WAY-100635), as well as event-related functional MRI with a Go/No-go task targeting the Cognitive Control network, neuropsychological assessment of affective perception, negative memory bias and Cognitive Control domains. There was also an exploratory genetic analysis with the serotonin transporter (5-HTTLPR) and monamine oxidase A (MAO-A) genes. In regression analyses, lower 5-HT1A binding potential (BP) in the MDD group was related to diminished engagement of the Cognitive Control network, slowed resolution of interfering cognitive stimuli, one element of Cognitive Control. In contrast, higher/normative levels of 5-HT1A BP in MDD (only) was related to a substantial memory bias toward negative information, but intact resolution of interfering cognitive stimuli and greater engagement of Cognitive Control circuitry. The serotonin transporter risk allele was associated with lower 1a BP and the corresponding imaging and cognitive IPs in MDD. Lowered 5HT 1a BP was present in half of the MDD group relative to the control group. Lowered 5HT 1a BP may represent a subtype including decreased engagement of Cognitive Control network and impaired resolution of interfering cognitive stimuli. Future investigations might link lowered 1a BP to neurobiological pathways and markers, as well as probing subtype-specific treatment targets. (shrink)

We propose an alternative resolution of Simpson's paradox in multiple classification experiments, using a different maximum likelihood estimator. In the center of our analysis is a formal representation of free choice and randomization that is based on the notion of incompatible measurements.We first introduce a representation of incompatible measurements as a collection of sets of outcomes. This leads to a natural generalization of Kolmogoroff's axioms of probability. We then discuss the existence and uniqueness of the maximum likelihood estimator for a (...) probability weight on such a generalized sample space, given absolute frequency data.As a first example, we discuss an estimation problem with censured data that classically admits only biased ad hoc estimators.Next, we derive an explicit solution of the maximum likelihood estimation problem for a large class of experiments that arise from various kids of compositions of sample spaces. We identify the (categorical) direct sum of sample spaces as a representation of “free choice,” and the (categorical) direct product as a representation of “randomization.”Finally, we apply the foregoing discussion to the case of multiple classification experiments in order to show that there is no Simpson's paradox if the difference between free choice and randomization is recognized in the structure of the experiment.A comparison between our new estimator and the “usual” calculation can be summarized as follows: Pooling the data over one classification factor in the “usual” way in fact destroys or ignores the information contained in it, whereas our proposed maximum likelihood estimator is a proper marginal over this factor that “averages out” the information contained in it. The estimators agree with each other in the case of proportional sample sizes. (shrink)

Homonyms, i.e. ambiguous words like ‘score’, have different meanings in different contexts. Previous research indicates that all potential meanings of a homonym are first accessed in parallel before one of the meanings is selected in a competitive race. If these processes are automatic, these processes of selection should even be observed when homonyms are shown subliminally. This study measured the time course of subliminal and supraliminal priming by homonyms with a frequent and a rare meaning in a neutral context, using (...) a lexical decision task. In the subliminal condition, priming across prime-target asynchronies ranging from 100 ms to 1.5 s indicated that the dominant meaning of homonyms was facilitated and the subordinate meaning was inhibited. This indicates that selection of meaning was much faster with subliminal presentation than with supraliminal presentation. Awareness of a prime might decelerate an otherwise rapid selection process. (shrink)

Economics has developed into one of the most specialised social sciences. Yet at the same time, it shares its subject matter with other social sciences and humanities and its method of analysis has developed in close correspondence with the natural and life sciences. This book offers an up to date assessment of economics in relation to other disciplines. -/- This edited collection explores fields as diverse as mathematics, physics, biology, medicine, sociology, architecture, and literature, drawing from selected contributions to the (...) 2005 Annual Conference of the European Society for the History of Economic Thought (ESHET). There is currently much discussion at the leading edges of modern economics about openness to other disciplines, such as psychology and sociology. But what we see here is that economics has drawn on (as well as contributed to) other disciplines throughout its history. In this sense, in spite of the increasing specialisation within all disciplines, economics has always been an open discipline and the chapters in this volume provide a vivid illustration for this. -/- Open Economics is a testament to the intellectual vibrancy of historical research in economics. It presents the reader with a historical introduction to the disciplinary context of economics that is the first of its kind, and will appeal to practising economists and students of the discipline alike, as well as to anybody interested in economics and its position in the scientific and social scientific landscape. -/- Table of Contents -/- Introduction: Economics in relation to other disciplines Richard Arena, Sheila Dow and Matthias Klaes Part I. Economics in relation to the humanities and social sciences 1. The social science of economics Brian J. Loasby 2. Economics and literature Bruna Ingrao 3. Happiness: what Kahneman could have learnt from Pietro Verri Pier Luigi Porta Part II. Economics in relation to the life and natural sciences 4. Newtonian physics, experimental moral philosophy and the shaping of political economy Sergio Cremaschi 5. Evolutionary biology and economic behaviour: re-visiting Veblen's instinct of workmanship Mark Harrison 6. Medicine and economics in pre-classical economics Alain Clément and Ludovic Desmedt Part III. Economics and mathematics 7. Mathematics as the role model for neoclassical economics Nicola Giocoli 8. The role of econometric method in economic analysis: A reassessment of the Keynes-Tinbergen debate, 1938-43 Giovanna Garrone and Roberto Marchionatti IV. Economics and architecture 9. Economics and architecture Maurice Lagueux 10. Economic policies and urban development in Latin America Michele Alacevich and Andrea Costa V. Economics and geography 11. ‘Space’ in economic thought Giovanna Vertova 12. Economics, geography and colonialism in the writings of William Petty Hugh Goodacre Part VI. Economics and sociology 13. Economics and sociology: Gustav Schmoller and Werner Sombart on social differentiation Joachim Zweynert 14. Is Homo Oeconomicus a 'bad guy'? Isabelle This Saint-Jean -/- . (shrink)

This document presents the Bonn PRINTEGER Consensus Statement: Working with Research Integrity—Guidance for research performing organisations. The aim of the statement is to complement existing instruments by focusing specifically on institutional responsibilities for strengthening integrity. It takes into account the daily challenges and organisational contexts of most researchers. The statement intends to make research integrity challenges recognisable from the work-floor perspective, providing concrete advice on organisational measures to strengthen integrity. The statement, which was concluded February 7th 2018, provides guidance on (...) the following key issues: § 1.Providing information about research integrity § 2.Providing education, training and mentoring § 3.Strengthening a research integrity culture § 4.Facilitating open dialogue § 5.Wise incentive management § 6.Implementing quality assurance procedures § 7.Improving the work environment and work satisfaction § 8.Increasing transparency of misconduct cases § 9.Opening up research § 10.Implementing safe and effective whistle-blowing channels § 11.Protecting the alleged perpetrators § 12.Establishing a research integrity committee and appointing an ombudsperson § 13.Making explicit the applicable standards for research integrity. (shrink)

In this volume specialists of medieval music and philosophy put the medieval 'musica' into the context of ideas and institutions in which it existed. The significance of 'musica' cannot be understood from a modern point of view since 'music' does not match the medieval 'musica'.

In this article, we discuss recent evidence from experimental economics on the impact of social preferences on workplace behavior. We focus on situations in which a single employer interacts with multiple employees. Traditionally, equity and efficiency have been seen as opposing aims in such work environments: individual pay-for-performance wage schemes maximize of efficiency but might lead to inequitable outcomes. We present findings from laboratory experiments that show under which circumstances partially incomplete contracts can create equitable work environments while at the (...) same time reaching surprisingly efficient outcomes. (shrink)

This volume explores the relation between legal reasoning and logic from both a historical and a systematic perspective. The topics addressed include, among others, conditional legal acts, disjunctions in legal acts, presumptions and conjectures, conflicts of values, Jørgensen´s Dilemma, the Rhetor´s Dilemma, the theory of legal fictions and the categorization of contracts. The unifying problematic of these contributions concerns the conditional structures and, more particularly, the relationship between legal theory and legal reasoning in the context of conditions.

Transdisciplinary research knits together knowledge from diverse epistemic communities in addressing social-environmental challenges, such as biodiversity loss, climate crises, food insecurity, and public health. This paper reflects on the roles of philosophy of science in transdisciplinary research while focusing on Indigenous and other subaltern forms of knowledge. We offer a critical assessment of demarcationist approaches in philosophy of science and outline a constructive alternative of transdisciplinary philosophy of science. While a demarcationist focus obscures the complex relations between epistemic communities, transdisciplinary (...) philosophy of science provides resources for meeting epistemic and political challenges of collaborative knowledge production. (shrink)

In: M. Carrier, D. Howard & J. Kourany (eds), Science and the Social: Knowledge, Epistemic Demands, and Social Values, Pittsburgh: University of Pittsburgh Press (im Erscheinen).

This article addresses ontological negotiations in the Global South through three case studies of community-based research in Brazil and Ghana. We argue that ontological perspectives of Indigenous and other subjugated communities require an ontological pluralism that recognizes the plurality of both representational tools and ways of being in the world. Locating these two readings of ontological pluralism in the politics of the Global South, the article highlights a wider dynamic from ontological paternalism to ontological diversity to ontological decolonization. We conclude (...) by arguing that this dynamic provides important lessons for reorienting agendas in social ontology through Southern Ontologies. (shrink)

Regular musical activity as a complex multimodal lifestyle activity is proposed to be protective against age-related cognitive decline and Alzheimer’s disease. This cross-sectional study investigated the association and interplay between musical instrument playing during life, multi-domain cognitive abilities and brain morphology in older adults from the DZNE-Longitudinal Cognitive Impairment and Dementia Study study. Participants reporting having played a musical instrument across three life periods were compared to controls without a history of musical instrument playing, well-matched for reserve proxies of education, (...) intelligence, socioeconomic status and physical activity. Participants with musical activity outperformed controls in global cognition, working memory, executive functions, language, and visuospatial abilities, with no effects seen for learning and memory. The musically active group had greater gray matter volume in the somatosensory area, but did not differ from controls in higher-order frontal, temporal, or hippocampal volumes. However, the association between gray matter volume in distributed frontal-to-temporal regions and cognitive abilities was enhanced in participants with musical activity compared to controls. We show that playing a musical instrument during life relates to better late-life cognitive abilities and greater brain capacities in OA. Musical activity may serve as a multimodal enrichment strategy that could help preserve cognitive and brain health in late life. Longitudinal and interventional studies are needed to support this notion. (shrink)

BackgroundIn the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort, participants underwent magnetic resonance imaging (MRI) of the brain, heart, and abdomen, that generated incidental findings (IFs). The approach to managing these unexpected results remain a complex issue. Our objectives were to describe the CAHHM policy for the management of IFs, to understand the impact of disclosing IFs to healthy research participants, and to reflect on the ethical obligations of researchers in future MRI studies.MethodsBetween 2013 and 2019, 8252 participants (...) (mean age 58 ± 9 years, 54% women) were recruited with a follow-up questionnaire administered to 909 participants (40% response rate) at 1-year. The CAHHM policy followed a restricted approach, whereby routine feedback on IFs was not provided. Only IFs of severe structural abnormalities were reported.ResultsSevere structural abnormalities occurred in 8.3% (95% confidence interval 7.7–8.9%) of participants, with the highest proportions found in the brain (4.2%) and abdomen (3.1%). The majority of participants (97%) informed of an IF reported no change in quality of life, with 3% of participants reporting that the knowledge of an IF negatively impacted their quality of life. Furthermore, 50% reported increased stress in learning about an IF, and in 95%, the discovery of an IF did not adversely impact his/her life insurance policy. Most participants (90%) would enrol in the study again and perceived the MRI scan to be beneficial, regardless of whether they were informed of IFs. While the implications of a restricted approach to IF management was perceived to be mostly positive, a degree of diagnostic misconception was present amongst participants, indicating the importance of a more thorough consent process to support participant autonomy.ConclusionThe management of IFs from research MRI scans remain a challenging issue, as participants may experience stress and a reduced quality of life when IFs are disclosed. The restricted approach to IF management in CAHHM demonstrated a fair fulfillment of the overarching ethical principles of respect for autonomy, concern for wellbeing, and justice. The approach outlined in the CAHHM policy may serve as a framework for future research studies.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/nct02220582. (shrink)