Impact of pollution prevention practices and green environmental practices on sustainable performance: Empirical evidence from Chinese SMEs.

Adequate protection of the environment is one of the hot spots of concern for all sectors of society due to severe environmental pollution. The solution to this issue is friendly management of the environment. With the rapid growth of Chinese Manufacturing SMEs for economic development, environmental pollution and abuse of resources are arising. To resolve these issues, Chinese manufacturing SMEs are accelerating the implementation of green innovation in their industries. However, it is a complex task that involves enterprise, government, and social considerations. Therefore, it is essential to identify the green drivers for this implementation. With a focus on China's current situation from previous research and views from experts, this study aims to investigate how Chinese Manufacturing Small and Medium-sized Enterprises (SMEs) are responding to resource misuse and environmental pollution by implementing green innovation, emphasising the role of artificial intelligence (AI) in improving environmental performance. This study primarily looks into the factors that influence the adoption of green innovations by analysing the growth paths of Chinese SMEs operating in highly polluting industries over a longer time frame than five years. Artificial Intelligence is a valuable tool for solving the issues of ecological degradation. A quantitative method has been implemented for the Chinese companies' samples from the deeply polluting industries for more than five years. The findings of this paper advise that the average board size, the governing board meetings, and organizational performance are positively connected with the Chinese firms' environmental process. Board independence and diversity of gender have irrelevant associations with ecological performance. A convenient threshold regression model has been used to accumulate the respondents' data. It also reveals that larger board sizes and more frequent governing board meetings are positively associated with improved environmental performance among these firms. The findings state the critical implications for the firm executives, policymakers, environmental activists, and regulators. This result supports the insight drained from the resource dependence, stakeholder, firm agency, and legitimacy theories.

Assessing personal protective equipment usage and its correlation with knowledge, attitudes, performance, and safety culture among workers in small and medium-sized enterprises.

BACKGROUND: The use of personal protective equipment (PPE) should be a culture of a workplace, and deeply rooted in worker behavior and attitude during their practice. According to the recent studies only 64% of the workers use PPE properly. The present study aims to investigate the utilization of PPE among workers in small and medium-sized enterprises (SMEs), and its relationship with knowledge, attitude, performance, and safety culture among workers. METHODS: This cross-sectional study was carried out using a questionnaire tool across SMEs in Kashan city in year 2023. The used tool included three questionnaires: demographic, safety culture, and knowledge, attitude and performance. Study papulation was 529 SMEs. Totally, the sample size was 369 persons and questionnaires were distributed among the workers of SMEs. Finally, SPSS software was used for statistical analysis and structural equation modeling. Various statistical tests including T-Test, ANOVA, RMSEA, CFI, TLI, and the chi-square ratio were employed. RESULTS: The mean values (standard deviation) of age and work experience were 35.19 (12.33), and 15.60 (1.69) years, respectively. Among the 369 participants, 267 participants (72.4%) indicated that they use some PPE, although not all types. However, 102 individuals (27.7%) do not employ any PPE. The lowest score for safety culture dimension was attributed to safety training at 1.58. The results of the final model indicate that the assumed relationships between variables, as outlined in the study objectives, were well established, with all connections proving statistically significant. CONCLUSION: It can be concluded that the missing of inadequate legal supervision for small industries exists. Therefore, it can be inferred that if supervision and regulation are enhanced for safety training and implementation that may lead to increased usage of PPE.

Does updating education curricula accelerate technology adoption in the workplace? Evidence from dual vocational education and training curricula in Switzerland.

In an environment of accelerating technological change and increasing digitalization, firms need to adopt new technologies faster than ever before to stay competitive. This paper examines whether updates of education curricula help to bring new technologies faster into firms' workplaces. We study technology changes and curriculum updates from an early wave of digitalization (i.e., computer-numerically controlled machinery, computer-aided design, and desktop publishing software). We take a text-as-data approach and tap into two novel data sources to measure change in educational content and the use of technology at the workplace: first, vocational education curricula and, second, firms' job advertisements. To examine the causal effects of adding new technology skills to curricula on the diffusion of these technologies in firms' workplaces (measured by job advertisements), we use an event study design. Our results show that curriculum updates substantially shorten the time it takes for new technologies to arrive in firms' workplaces, especially for mainstream firms.

Analyzing the effects of climate risk on discouraged borrowers: Deciphering the contradictory forces.

We examine the impact of climate risk on discouraged borrowers among small and medium-sized enterprises (SMEs) in the eurozone, using a unique European Central Bank dataset focusing on the demand side of credit markets. We argue that two opposing channels may exist in this relationship: Either climate risk has a negative effect stemming from increased demand for sustainable or climate-resilient projects that enhance creditworthiness, or climate risk has a positive effect arising from heightened climate uncertainty and risk aversion, leading to credit self-rationing among SMEs. Our findings reveal that heightened climate risk prompts SMEs to self-ration credit, leading to higher probabilities of discouraged borrowers. Our research deepens the understanding of the impact of climate risk on credit-related decisions, stressing the need for proactive measures to integrate climate risk assessments into regulatory frameworks and lending practices. The findings underscore the vulnerability of SMEs to climate risk, emphasizing emphasizing the importance of tailored support mechanisms for economic resilience.

Requirements and Barriers for Human-Centered SMEs.

With the advantages of new technologies and rising demand from customers, it is necessary to improve the manufacturing process. This necessity was recognized by the industry; therefore, the concept of Industry 4.0 has been implemented in various areas of manufacturing and services. The backbone and main aspect of Industry 4.0 is digitalization and the implementation of technologies into processes. While this concept helps manufacturers with the modernization and optimization of many attributes of the processes, Industry 5.0 takes a step further and brings importance to the human factor of industry practice, together with sustainability and resilience. The concept of Industry 5.0 contributes to the idea of creating a sustainable, prosperous, and human-friendly environment within companies. The main focus of the article is to analyze the existing literature regarding what is missing from the successful implementation of human centricity into industry practice, namely in small and medium-sized factories (SMEs). These findings are then presented in the form of requirements and barriers for the implementation of human centricity into SME factories, which can serve as guidelines for implementing human-centered manufacturing using axiomatic design theory in SMEs, which can serve as a roadmap for practitioners.

Financing sources, green investment, and environmental performance: Cross-country evidence.

This article investigates the influence of financing sources and financial constraints on green investment, based on a study conducted with a sample of Eastern European SMEs from 2018 to 2020. We constructed a green investment proxy using principal component analysis, revealing two principal pillars: pure green investment and mixed green investment. Employing two-stage least squares regression analysis (2SLS) and instrumental probit (IV Probit), our results demonstrate that internal finance positively impacts green investment. Conversely, we find that leverage and financial constraints negatively correlate with green investment and environmental performance. The findings of this study provide compelling evidence that SMEs operating in the Eastern European region face significant financial constraints, impeding their ability to adopt responsible investments aimed at reducing their considerable environmental footprints. These results hold valuable implications for both managers and policymakers, emphasizing the importance of facilitating increased access to debt and devising green financial incentives to promote environmentally responsible investments among Eastern European SMEs, particularly during periods of conflicts.

Outcome assessment of a complex mental health intervention in the workplace. Results from the MENTUPP pilot study.

OBJECTIVE: Multicomponent interventions are recommendable to achieve the greatest mental health benefits, but are difficult to evaluate due to their complexity. Defining long-term outcomes, arising from a Theory of Change (ToC) and testing them in a pilot phase, is a useful approach to plan a comprehensive and meaningful evaluation later on. This article reports on the pilot results of an outcome evaluation of a complex mental health intervention and examines whether appropriate evaluation measures and indicators have been selected ahead of a clustered randomised control trial (cRCT). METHODS: The MENTUPP pilot is an evidence-based intervention for Small and Medium Enterprises (SMEs) active in three work sectors and nine countries. Based on our ToC, we selected the MENTUPP long-term outcomes, which are reported in this article, are measured with seven validated scales assessing mental wellbeing, burnout, depression, anxiety, stigma towards depression and anxiety, absenteeism and presenteeism. The pilot MENTUPP intervention assessment took place at baseline and at 6 months follow-up. RESULTS: In total, 25 SMEs were recruited in the MENTUPP pilot and 346 participants completed the validated scales at baseline and 96 at follow-up. Three long-term outcomes significantly improved at follow-up (p < 0.05): mental wellbeing, symptoms of anxiety, and personal stigmatising attitudes towards depression and anxiety. CONCLUSIONS: The results of this outcome evaluation suggest that MENTUPP has the potential to strengthen employees' wellbeing and decrease anxiety symptoms and stigmatising attitudes. Additionally, this study demonstrates the utility of conducting pilot workplace interventions to assess whether appropriate measures and indicators have been selected. Based on the results, the intervention and the evaluation strategy have been optimised.

Work-related stressors and coping behaviors among leaders in small and medium-sized IT and technological services enterprises.

BACKGROUND: Occupational health interventions for leaders are underrepresented in small and medium-sized enterprises (SMEs). When creating and developing effective occupational health interventions, identification of the specific needs of the target group is regarded as an essential step before planning an intervention. Therefore, the aim of this study was (1) to examine the subjectively experienced work-related stressors of leaders in small and medium-sized IT and technological services enterprises, (2) to explore coping behaviors leaders use to deal with the experienced work-related stressors, (3) to investigate resources supporting the coping process and (4) to identify potentially self-perceived consequences resulting from the experienced stressors. METHODS: Ten semi-structured interviews with leaders in small and medium-sized IT and technological services enterprises were conducted. The interviews were transcribed and analyzed with content-structuring qualitative content analysis in accordance to Kuckartz. RESULTS: Leaders in small and medium-sized IT and technological services enterprises experience various stressors caused by work organization as well as industry-related stressors and other work-related stressors. To address the experienced stressors, leaders apply problem focused coping behaviors (e.g. performing changes on structural and personal level), emotional focused coping behaviors (e.g. balancing activities, cognitive restructuring) as well as the utilization of social support. Helpful resources for the coping process include organizational, social and personal resources. As a result of the experienced work-related stressors, interviewees stated to experience different health impairments, negative effects on work quality as well as neglect of leisure activities and lack of time for family and friends. CONCLUSION: The identified experienced work-related stressors, applied coping behaviors, utilized resources and emerging consequences underpin the urgent need for the development and performance of health-oriented leadership interventions for leaders in small and medium- sized IT and technological services. The results of this study can be used when designing a target-oriented intervention for the examined target group.

The influence of meaningful work on the mental health of SME employees in the COVID-19 era: can coping strategies mediate the relationship?

BACKGROUND: Stress, depression, and anxiety are prevalent issues among SME employees during the COVID-19 pandemic. Even while having meaningful work that expressively contributes to individual growth has been related to improving mental health, employees' work may also need to adopt coping strategies to increase outcomes. The purpose of this study was to examine the relationship between meaningful work (positive meaning, meaning-making, and greater good motivations) and mental health, as well as coping strategies (problem-focused and emotion-focused) as a mediator of this relationship. METHODS: Meaningful work, coping strategies, and mental health were evaluated in empirical research based on a sample of 462 SME employees working in Malaysia. Structured questionnaires were used to collect the data and analyze it through Structural Equation Modelling (SEM) using AMOS 21.0. RESULTS: The findings of the study show the importance of meaningful work in influencing the mental health of SME employees, particularly during a crisis like the COVID-19 pandemic. This suggests that the more they value and see their work as meaningful, the more capable they are of dealing with limitations and mental health problems associated with crises. The study also discovered a partial mediating role for coping strategies between employees' mental health and meaningful work. CONCLUSION: This study encourages employees to constantly feel connected and discover continued possibilities to work and learn even during crisis situations. In order to improve human resource efficiency in emerging markets, managers and owners of SMEs must implement the model developed by the researchers.

Developing a framework for evaluation: a Theory of Change for complex workplace mental health interventions.

BACKGROUND: There is a gap between the necessity of effective mental health interventions in the workplace and the availability of evidence-based information on how to evaluate them. The available evidence outlines that mental health interventions should follow integrated approaches combining multiple components related to different levels of change. However, there is a lack of robust studies on how to evaluate multicomponent workplace interventions which target a variety of outcomes at different levels taking into account the influence of different implementation contexts. METHOD: We use the MENTUPP project as a research context to develop a theory-driven approach to facilitate the evaluation of complex mental health interventions in occupational settings and to provide a comprehensive rationale of how these types of interventions are expected to achieve change. We used a participatory approach to develop a ToC involving a large number of the project team representing multiple academic backgrounds exploiting in tandem the knowledge from six systematic reviews and results from a survey among practitioners and academic experts in the field of mental health in SMEs. RESULTS: The ToC revealed four long-term outcomes that we assume MENTUPP can achieve in the workplace: 1) improved mental wellbeing and reduced burnout, 2) reduced mental illness, 3) reduced mental illness-related stigma, and 4) reduced productivity losses. They are assumed to be reached through six proximate and four intermediate outcomes according to a specific chronological order. The intervention consists of 23 components that were chosen based on specific rationales to achieve change on four levels (employee, team, leader, and organization). CONCLUSIONS: The ToC map provides a theory of how MENTUPP is expected to achieve its anticipated long-term outcomes through intermediate and proximate outcomes assessing alongside contextual factors which will facilitate the testing of hypotheses. Moreover, it allows for a structured approach to informing the future selection of outcomes and related evaluation measures in either subsequent iterations of complex interventions or other similarly structured programs. Hence, the resulting ToC can be employed by future research as an example for the development of a theoretical framework to evaluate complex mental health interventions in the workplace.

Cyber risk assessment in small and medium-sized enterprises: A multilevel decision-making approach for small e-tailors.

The role played by information and communication technologies in today's businesses cannot be underestimated. While such technological advancements provide numerous advantages and opportunities, they are known to thread organizations with new challenges such as cyberattacks. This is particularly important for small and medium-sized enterprises (SMEs) that are deemed to be the least mature and highly vulnerable to cybersecurity risks. Thus, this research is set to assess the cyber risks in online retailing SMEs (e-tailing SMEs). Therefore, this article employs a sample of 124 small e-tailers in the United Kingdom and takes advantage of a multi-criteria decision analysis (MCDA) method. Indeed, we identified a total number of 28 identified cyber-oriented risks in five exhaustive themes of "security," "dependency," "employee," "strategic," and "legal" risks. Subsequently, an integrated approach using step-wise weight assessment ratio analysis (SWARA) and best-worst method (BWM) has been employed to develop a pathway of risk assessment. As such, the current study outlines a novel approach toward cybersecurity risk management for e-tailing SMEs and discusses its effectiveness and contributions to the cyber risk management literature.

Enhancing Cyber-Resilience for Small and Medium-Sized Organizations with Prescriptive Malware Analysis, Detection and Response.

In this study, the methodology of cyber-resilience in small and medium-sized organizations (SMEs) is investigated, and a comprehensive solution utilizing prescriptive malware analysis, detection and response using open-source solutions is proposed for detecting new emerging threats. By leveraging open-source solutions and software, a system specifically designed for SMEs with up to 250 employees is developed, focusing on the detection of new threats. Through extensive testing and validation, as well as efficient algorithms and techniques for anomaly detection, safety, and security, the effectiveness of the approach in enhancing SMEs' cyber-defense capabilities and bolstering their overall cyber-resilience is demonstrated. The findings highlight the practicality and scalability of utilizing open-source resources to address the unique cybersecurity challenges faced by SMEs. The proposed system combines advanced malware analysis techniques with real-time threat intelligence feeds to identify and analyze malicious activities within SME networks. By employing machine-learning algorithms and behavior-based analysis, the system can effectively detect and classify sophisticated malware strains, including those previously unseen. To evaluate the system's effectiveness, extensive testing and validation were conducted using real-world datasets and scenarios. The results demonstrate significant improvements in malware detection rates, with the system successfully identifying emerging threats that traditional security measures often miss. The proposed system represents a practical and scalable solution using containerized applications that can be readily deployed by SMEs seeking to enhance their cyber-defense capabilities.

Global supply chains risks and COVID-19: Supply chain structure as a mitigating strategy for small and medium-sized enterprises.

After the COVID-19 pandemic, more research is needed to understand how the impacts of global events differ among alternative network structures in the presence of supply chain risks, and how relevant these potential risk mitigation strategies are for Small and Medium Enterprises(SMEs). Thus, our main motivation is to show how SMEs can configure their supply chains, and cost-effectively mitigate the risk created by major disruptions. We combined a case study with a simulation model. The results suggest the greater usefulness of certain network configuration strategies (e.g., collaboration, multi-sourcing) compared to others during catastrophic events. Our results indicate that SMEs can avoid suffering more harm than larger competitors by adopting strategies consisting of an adequate mix of proactive and reactive elements, and that an effective proactive strategy involves building flexibility by increasing the number of geographically spread supply chain partners, allowing for deeper discounts to preserve demand without hurting profits.

Stakeholder pressure and innovation capacity of SMEs in the COVID-19 pandemic: Mediating and multigroup analysis.

During environmental crises, it has always been particularly interesting to investigate how companies, specifically small- and mid-sized enterprises (SMEs), find solutions to survive and learn how to act in adverse situations. We conducted our study during the current coronavirus pandemic to analyse how stakeholder pressure affects both the innovation capabilities of SMEs and their firm performance. On the one hand, we examine whether the market and financial performance are better in the presence of less stakeholder pressure. On the other hand, we analyse whether SMEs implement internal mechanisms that enhance their innovation capacity to solve external problems caused by greater stakeholder pressure, which in turn affects firm performance. Our main findings show that during the pandemic, stakeholder pressure is related to the innovative capacity of SMEs; therefore, the higher the pressure, the more important the innovative response of SMEs. However, with higher pressure, the company's performance would be directly reduced in the short term, as the conditions set would be more unfavourable. Innovation capacity also plays a mediating role in preventing poor business performance because of increased stakeholder pressure. Owing to the importance of the chief executive officer (CEO) in SMEs, we test, through multigroup analysis, the differences based on the CEO's educational level. For example, commitment to innovation in SMEs may be more important for managers with higher education. Finally, our findings show how managers can learn to face new challenges in unfavourable environments.

The impact of trade facilitation on African SMEs' performance.

Whilst contemporary literature indicates that the business environment (BE) impacts almost all entrepreneurial activities, there are indications that the unique business and institutional setting in Africa (with its challenges and opportunities) and the nature of SMEs (their strengths and weaknesses), among other factors, lead to the context-specific impact of regulations on the performance of African SMEs. Using regressions and propensity score matching methods on a panel of 39,461 firm observations (27 African countries) from the World Bank Enterprise Surveys, we unearthed evidence to suggest that whilst enabling tax administration and business licensing regulations improve SMEs' performance, trade facilitation impedes African SMEs' performance. Furthermore, the institutional context of competition (from foreign firms) worsens trade facilitation's negative impact on African SMEs' performance. These findings suggest a fine-tuning of BE regulations in African countries. Trade facilitation, for example, must be carefully thought through and implemented in a way to benefit SMEs.

ECB unconventional monetary policy and SME access to finance.

Small- and medium-sized enterprises (SMEs) account for two-thirds of employment in the euro area which makes them a priority for the transmission of monetary policy to the real economy. SMEs in Europe experienced a credit crunch following the sovereign debt crisis. Over the period 2014-2019, the European Central Bank (ECB) engaged in unconventional monetary policy (UMP) to restore funding conditions in the euro area, to support stronger economic growth and higher inflation. We use the ECB/EC Survey on the Access to Finance of Enterprises to examine the relationship between monetary policy and SME access to finance in countries that were most affected by the crisis as follows: Greece, Ireland, Italy, Portugal and Spain. We show that the implementation of UMP increases the probability that firms with higher debt-to-assets ratio remain credit constrained in stressed countries, although this effect becomes insignificant in non-stressed countries. Our findings suggest that monetary policy is transmitted unevenly to leveraged SMEs across jurisdictions. Additionally, we find little evidence that risky firms are credit constrained during periods of UMP, when risk is measured from the firms' own viewpoint. However, our heterogenous analysis shows that smaller and younger firms-which are also considered to be risky-remain credit constrained over this period. Policy should ensure that UMP trickles down to SMEs regardless of their size, age or location. Tweetable line: Leveraged SMEs in stressed countries are more likely to remain credit constrained even when monetary policy is expansionary. Policy must do more to support small and young firms' access to credit to facilitate higher investment and growth.

Business groups' internal labour markets and SME labour productivity.

Labour market regulation constrains small and medium-sized enterprises' (SMEs) ability to minimize redundant labour. However, it is often neglected that many SMEs might circumvent these constraints by accessing a business group's internal labour market (ILM). In this study, we analyse whether SMEs with ILM access-i.e., with an increasing number of sister group companies in the same subnational region-industry-enjoy a labour productivity premium and whether this potential productivity premium depends on the bargaining power of labour. Because intra-group reallocation of redundant personnel often involves substantial changes in employment conditions, we argue that the value of ILM access might be reduced when the bargaining power of workers is high as they can oppose the reallocation or demand significant compensation. Using a panel of 119,801 European SMEs during 2011-2019 (639,675 firm-year observations), we find that SMEs with ILM access show relatively higher labour productivity. Further, our findings suggest that this productivity premium is higher in those contexts associated with lower labour bargaining power. Supplementary Information: The online version contains supplementary material available at 10.1007/s11187-023-00780-4.

Does the bank-firm human relationship still matter for SMEs? The game-changing role of digitalization.

Noteworthy contributions have highlighted that human contact is a considerable factor in bank-firm relationships. It allows the acquisition of soft information, which alleviates information asymmetries and increases the use of bank debt. The advent of digital technologies in the information collection process open new horizons and change the role of personal contacts in bank-firm interactions, as entrepreneurs visit bank branches less frequently. This study uses a large sample of Italian SMEs from 2011 to 2020 and finds that the rapid increase and use of digital instruments have reduced the positive influence of physical closeness between banks and SMEs on the indebtedness levels. Interestingly, our study has also found that the COVID-19 crisis did not amplify this moderating effect. Results support theories that human contact is an important factor in bank-firm relationships because it allows the acquisition of soft information, which alleviates information asymmetries and increases the use of bank debt. Our study suggests that close human ties are still extremely relevant and digitalization should be exploited to support the collection of the kind of qualitative soft information that is crucial in debt negotiations.

How does government-backed finance affect SMEs' crisis predictors?

This paper estimates the impact of public guarantees on crisis predictive indicators among small and mid-size enterprises (SMEs). We use a confidential database provided by the Italian Ministry of Economic Development on the universe of guarantees granted by the Central Guarantee Fund. We apply difference-in-difference regressions and propensity-score matching estimators to a sample of approximately 40,000 SMEs over the 2010-2018 period. We find that obtaining a public guarantee improves profitability both in the short- and medium-term. On the other hand, SMEs' financial health worsens in the short run, but financial burdens are alleviated 2 years after the issuance of a guarantee. The economic and financial effects of government-backed loans are amplified for micro-sized firms, companies operating in the service sector and direct guarantees. Our results can thus support public authorities in designing credit guarantee schemes capable of preventing SMEs' zombification and protecting them from the risk of debt overhang.

Counting on U training to enhance trusting relationships and mental health literacy among business advisors: protocol for a randomised controlled trial.

BACKGROUND: Financial distress is thought to be a key reason why small-medium enterprise (SME) owners experience higher levels of mental health conditions compared with the broader population. Business advisors who form trusting, high-quality relationships with their SME clients, are therefore well placed to: (1) help prevent/reduce key sources of financial distress, (2) better understand the business and personal needs of their clients and, (3) recognise the signs and symptoms of mental health conditions and encourage help-seeking where appropriate. The aim of this study is to compare the effectiveness of relationship building training (RBT) combined with mental health first aid (MHFA) training for business advisors with MHFA alone, on the financial and mental health of their SME-owner clients. METHODS: This is a single blind, two-arm randomised controlled trial. Participants will be business advisors who provide information, guidance and/or assistance to SME owner clients and are in contact with them at least 3 times a year. The business advisors will invite their SME-owner clients to complete 3 online surveys at baseline, 6- and 12-months. Business advisors will be randomised to one of two conditions, using a 1:1 allocation ratio: (1) MHFA with RBT; or (2) MHFA alone, and complete 3 online surveys at baseline, 2- and 6-months. Primary outcomes will be measured in the business advisors and consist of the quality of the relationship, stigmatizing attitude, confidence to offer mental health first aid, quality of life and provision of mental health first aid. Secondary outcomes will be measured in the SME owners and includes trust in their business advisors, the quality of this relationship, financial wellbeing, financial distress, psychological distress, help-seeking behaviour, and quality of life. To complement the quantitative data, we will include a qualitative process evaluation to examine what contextual factors impacted the reach, effectiveness, adoption, implementation, and maintenance of the training. DISCUSSION: As there is evidence for the connections between client trust, quality of relationship and financial and mental wellbeing, we hypothesise that the combined RBT and MHFA training will lead to greater improvements in these outcomes in SME owners compared with MHFA alone. TRIAL REGISTRATION: ClinicalTrials.gov : NCT04982094 . Retrospectively registered 29/07/2021. The study started in February 2021 and the recruitment is ongoing.