Financial Health Research Articles

Multiple Linear Regression Analysis of Factors Contributing to the Spread of Cholera in Kenya from 2000 to 2022

Cholera is a deadly disease caused by consumption of either food or water that is contaminated with bacterium known as Vibro cholerae. In the 19<sup>th</sup> century, Cholera had spread across the globe from its original source in Ganges Delta, India. This research aimed to investigated the factors contributing to the spread of Cholera in Kenya from 2000 to 2022. The key objective was to fit a multiple linear regression model which aid in determining the goodness of fit as well as examining the relationship between different types of drinking water and spread of Cholera. Secondary data was obtained from United Nations International Children’s Emergency Fund (UNICEF) and World Health Organization (WHO). The results showed a strong positive linear relationship between Surface water and proportion of population affected by Cholera. 88% total variation in the proportion of population being affected by Cholera can be explained by the Unimproved Basic water (UBW), Surface water (SW) and Least Basic drinking water (LBW). Significantly this research encouraged the use of the least basic drinking water which clearly showed an inverse proportion to the proportion of population affected by Cholera. In addition to that, the researchers recommend improved access to clean water and create awareness on the dangers of using untreated water.

The CJEU’s Unintelligible Impairment of the Financial Health of EU Performers: Ever-Increasing Suspense in Neighbouring Rights

Abstract With the RAAP ruling in 2020, the Court of Justice of the European Union (CJEU) delivered a judgment with a far-reaching impact, both on the autonomy of Member States within the making of reservations under international treaties, and on revenues for collecting societies and neighbouring rightsholders in the EU. The controversial part of the judgment states that entering reservations on the granting of equitable remuneration for neighbouring rights on the basis of international treaties should only take place at EU level. This effectively leaves no autonomy to Member States within the principle of reciprocity, contrary to former popular belief by many Member States and scholars. The US has entered reservations with regard to EU countries under Art. 15(3) WIPO Performances and Phonograms Treaty (WPPT), thus no remuneration is disbursed for performances by EU artists in the US. Due to the US repertoire’s large presence in the EU, the latter’s performers will be left with a considerably smaller share of the revenues to be distributed by EU collecting societies. The European Commission must urgently finish the ongoing research and consultation on RAAP. Right now, too many requests by interest groups remain unanswered. The recommended (and hoped for) route is for the EU to invoke the principle of reciprocity and enter reservations for other WPPT parties that have entered such reservations with regard to EU countries. An extensive arrangement regarding reservations is necessary, also regarding situations where the relationship between fundamental rights and reciprocity provisions is currently unknown.

Relationship between bank value, tax avoidance, and profitability

This study explores the intricate relationships between bank value, tax avoidance, and profitability, which significantly affect the stability and strategies of financial institutions worldwide. Understanding these connections is vital for comprehending the financial dynamics of banks, key players in economic growth and stability. The study focuses on these three factors due to their intertwined roles in shaping fiscal policy effectiveness, shareholder satisfaction, and overall financial health. The aim of this study is to explore the relationships between the bank value, tax avoidance and profitability aiming to clarify their interactions and their impact on the Jrdanian banks. Ordinary Least Squares regression analysis is employed using a mixed-methods approach, including quantitative regression analysis and qualitative assessments. The study results reveal a significant direct link between bank tax avoidance and profitability. The increase in Return on Assets is associated with a substantial increase in tax avoidance. In the expanded model, bank value and size did not exhibit statistically significant incremental information over profitability in explaining tax avoidance. Profitability emerges as a dominant factor, overshadowing the potential impact of size and value. The results underscore profitability as a key driver in bank tax strategies, highlighting a potential area for regulatory scrutiny and strategic realignment. In conclusion, the study underscores the pivotal influence of bank profitability on tax avoidance strategies. Policymakers, practitioners, and researchers are encouraged to recognize the prominence of profitability in formulating tax strategies.

An Evaluation of the Impact of Merger and Acquisition on the Financial Health of Banks: A Case Study of Atlas Mara Bank – Zambia

An Evaluation of the Impact of Merger and Acquisition on the Financial Health of Banks: A Case Study of Atlas Mara Bank – Zambia

A Scoping Review of Health Equity Interventions in Governmental Public Health.

Despite major efforts in research, practice, and policy, racial and ethnic disparities in health and health care persist in the United States. Interventions in collaboration with governmental public health may provide ways to address these persistent racial and ethnic health and health care disparities and improve health outcomes. To conduct a comprehensive review of health equity interventions performed in collaboration with public health agencies. This scoping review includes intervention studies from Ovid MEDLINE, PsycINFO, and Academic Search Premier, published between 2017 and 2023. The search strategy used terminology focused on 4 concepts: race/ethnicity, equity, health departments, and epidemiologic studies. The following inclusion criteria were determined a priori: (1) intervention tailored to reduce racial/ethnic health disparities, (2) public health department involvement, (3) health outcome measures, (4) use of epidemiologic study methods, (5) written in English, (6) implemented in the United States, (7) original data (not a commentary), and (8) published between January 2017 and January 2023. This review focused primarily on 4 dimensions of racial health equity interventions including intervention components, intervention settings, intervention delivery agents, and intervention outcomes. This review indicated that health equity interventions involving public health agencies focused on the following categories: (1) access to care, (2) health behavior, (3) infectious disease testing, (4) preventing transmission, and (5) cancer screening. Critical strategies included in interventions for reaching racial/ethnic minoritized people included using community settings, mobile clinics, social media/social networks, phone-based interventions, community-based workers, health education, active public health department involvement, and structural/policy change. This scoping review aims to provide an evidence map to inform public health agencies, researchers, and funding agencies on gaps in knowledge and priority areas for future research and to identify existing health equity interventions that could be considered for implementation by public health leaders.

Medicaid Enrollment and Intergenerational Transfers of Wealth Among Older Adults.

Medicaid look-back periods are meant to prevent Medicaid applicants from gifting assets to meet eligibility requirements. These policies have the potential to affect families across generations given their ability to restrict the transfer of assets between parent and child. Using 2008-2018 data from the Health and Retirement Study, this study analyzed the estate planning and familial wealth transfer behaviors of a cohort of older adults aged 65 and older who became Medicaid recipients during a 10-year period. There were 8,347 respondents aged 65 and older in 2008 and 11.96% of respondents who were not Medicaid recipients at baseline became recipients over the study period. A little more than one third (36.47%) of Medicaid recipients participated in estate planning and asset transfer prior to becoming a recipient, with significant differences among select demographic characteristics. Married recipients were more likely to transfer money compared to their widowed counterparts (51.69% compared to 36.44%; p < .001) and transferred larger amounts compared to those unmarried ($16,286.94 compared to 5,379.13). White, well-educated, married, men participated in higher rates of estate planning, likely a reflection of who has access to resources to make necessary arrangements early. This analysis concludes that more structurally advantaged groups are more likely to engage in estate planning prior to Medicaid enrollment. This analysis demonstrates that some individuals may circumvent Medicaid policies like look-back periods and estate recovery, while others cannot. Policymakers should consider policies that promote the financial health of low-income families.

The Impacts of Accounting Information on the Cost of Capital of a Company

The cost of capital is heavily influenced by a company's accounting information. The cost of capital is the rate of return that investors want in exchange for putting their money into a business. Accounting information has an indirect effect on society via things like disclosure and openness. Companies get more trust from investors and the public when they make their financial data easily accessible and easy to understand. Since investors will have a clearer picture of the company's financial performance, they may be more willing to lend money at a reduced interest rate as a result of this greater openness. Another abstract influence is the appraisal of financial success. Investors and lenders use financial statements and other forms of accounting information to assess a company's profitability and financial health. Investors may get a sense of a company's profitability, asset management, and cash flow capabilities by looking at the company's income statement, balance sheet, and cash flow statement. A reduced cost of capital may be possible if financial performance indicators provide a positive picture of the company's financial health. Risk may be better evaluated with the use of accounting data. Financial data is used by investors in assessing the safety of a firm. Investors may get a sense of the company's financial health, leverage, and liquidity by examining financial statements and ratios. A reduced cost of capital is more likely to be offered by investors to a firm that has a good financial position and a low risk profile. In addition to improving openness and easing the evaluation of financial performance and risk, accounting information also affects the cost of capital. The cost of capital might be reduced if investors have more faith in a company because of the transparency it displays in its financial dealings. KEYWORDS: Accounting information, Cost of capital, Transparency and disclosure, Reliable financial information, Investor confidence, Lower risks, financial performance assessment

Emerging trends of marketing surgical cases in Africa: Balancing health financing strategies, exploitation and ethical concerns

Emerging trends of marketing surgical cases in Africa: Balancing health financing strategies, exploitation and ethical concerns

U.S. Medical School Participation in Nationally Funded Biomedical Research: A New Accounting of NIH Award Dollars.

To better understand the amount of National Institutes of Health (NIH) funding received by U.S. medical schools with Liaison Committee on Medical Education-accredited medical education programs, the Association of American Medical Colleges (AAMC) developed a new methodology that crosswalks faculty NIH grants with medical schools and their affiliated organizations (e.g., teaching hospitals). This approach offers a more comprehensive and methodologically transparent accounting of NIH extramural funding to academic medicine than existing processes.The AAMC Crosswalk utilized publicly available grants data from the NIH and resources unique to the AAMC, such as the Faculty Roster and Council of Teaching Hospitals and Health Systems records. Using a multi-step algorithm, the AAMC Crosswalk linked individual faculty with NIH grants, their organizations, and partner medical schools, aggregated at the level of the medical school and its affiliated organizations for fiscal year (FY) 2017-2021.The AAMC Crosswalk attributed on average $3.7 billion more per year in NIH funding to U.S. medical schools, representing a 24% increase compared to the NIH and Blue Ridge Institute for Medical Research (BRIMR) methodologies. In FY 2021, the AAMC Crosswalk attributed 60% of NIH funding to U.S. medical schools compared with 47% by NIH and 50% by BRIMR. An exploration of limitations showed no medical school affiliations were missed by the AAMC Crosswalk among 90 randomly sampled organizations, and medical school affiliations for 30 randomly sampled principal investigator faculty members were attributed correctly.These findings indicate that academic medicine's contribution to biomedical research may be greater than historically reported. Systematically accounting for grants awarded to faculty across medical schools and their affiliated organizations provides a more comprehensive understanding of NIH funding to U.S. medical schools. The AAMC Crosswalk provides a new tool to better estimate the true investment and role of academic medicine in advancing biomedical research.

Economic burden and economic impact associated with non-communicable diseases among countries of World Health Organization South-East Asia Region - a systematic review protocol.

The objective of this systematic review is to synthesize studies on economic burden and economic impact of noncommunicable diseases (NCDs) in the World Health Organization South-East Asian Region (WHO SEAR) countries. WHO SEAR countries represent 8.6% of the world's population and 75% of all deaths in this region are attributable to NCDs. In addition, there is a pattern of low government spending on health in SEAR countries, leading to a high proportion of health financing by patients', risking impoverishment for households. We will consider observational (cross-sectional, cohort, and case-control) and interventional (either single arm or comparative) studies that report economic burden (direct and indirect costs, out-of-pocket expenditure) and economic impact (catastrophic health expenditure, hardship financing, impoverishment, and gross domestic product impact at individual, household, and/or country levels). This includes government surveys, surveillance, and secondary data analyses for one or more NCDs prevalent in the WHO SEAR. We will conduct a comprehensive search for relevant studies in databases, including PubMed (MEDLINE), Embase (Ovid), Scopus, Web of Science, Google Scholar, and gray literature with no date limits. Two independent reviewers will screen titles and abstracts, followed by full-text screening. Included studies will be critically appraised for quality. Data will be extracted accordingly and, if possible, random effects meta-analyses will be conducted on the pooled data for resource utilization and costs (including burden and impact), presenting the degree of variation between studies. The characteristics and results of the included studies will be narratively summarized with accompanying tables. PROSPERO CRD42023421302.

The role of governance in the digital transformation of healthcare: Results of a survey in the WHO Europe Region

Optimal governance is among the key facilitators of the digital transformation of health systems intended to improve access to healthcare, quality, safety, and efficiency, and to attain universal health coverage. This paper highlights the findings of a survey assessing the status of governance of digital health in the WHO European Region.The 2022 survey is a continuation of the 2015 WHO Global Survey on eHealth. The survey focused on national digital health governance, monitoring and evaluation of digital health interventions, and funding and investment in digital health and was conducted through April to October 2022. All 53 Member States of the WHO European Region participated in the survey.The results showed that 83% of the Member States reported having a national digital health strategy in place, and 79% of the Member States reported having a health information system strategy. Most of the priorities of the national digital health strategies were devoted to increasing the accessibility, quality, safety, and efficiency of the health systems, strengthening health information systems, and improving information sharing and interoperability of data. Measures to ensure equity in access to digital healthcare services were directed towards improving broadband connectivity, information and communication technology, digital literacy, and digital health promotion. Oversight for the implementation and operation of the national digital health strategies are mostly delegated to government agencies. The prime source of funding for digital health programs was public funding, though a combination of funding sources was also noted. This analysis revealed increasing adoption of national digital health strategies for access to healthcare and creation of digital health agencies and funding programs for digital health.

Can health financing programmes reduce food insecurity in a developing country?

Despite the devastating effects of out-of-pocket healthcare expenditures on households' financial outlays, which potentially stifle household resources needed for food consumption, the health financing program-food insecurity nexus is yet to receive much needed attention in the literature. This study makes a significant contribution by investigating the effect of health financing program, conceptualised as membership of a National Health Insurance Scheme, on household food insecurity using the food insecurity experience scale (FIES) and several quasi-experimental methods. Using data from the seventh round of the Ghana Living Standards Survey, our endogeneity-corrected results indicate that membership of a health financing program can contribute to reduction in household food insecurity. The results are robust to alternative conceptualisations of food insecurity and different quasi-experimental methods. The effect of health financing programme membership on food insecurity is more pronounced among urban and female-headed households. Our findings further point to household savings as an important channel through whichmembership ofhealth financing program reduces food insecurity.

Identifying Challenges and Solutions for Improving Access to Mental Health Services for Rural Youth: Insights from Adult Community Members.

Semi-structured, key informant interviews were conducted by telephone with adult community members, including parents, teachers, and healthcare providers. Participants answered questions related to barriers to mental healthcare access that confront youth and approaches to improving access. Detailed, de-identified field notes were analyzed using conventional content analysis. Limited resources and stigma were the two primary barriers to accessing mental healthcare that youth encounter in the community. Limited resources included lack of services and transportation, inconsistent funding and mental health programming, and workforce shortages. Stigma associated with seeking mental healthcare was of particular concern for youth with diverse identities who experience additional stigma. Improving access to mental healthcare for rural youth will require building a strong mental health workforce and championing efforts to reduce stigma associated with help-seeking.

Assessing the Impact of COVID-19 on the Financial Health of Health Insurance Companies in India

Assessing the Impact of COVID-19 on the Financial Health of Health Insurance Companies in India

Digital technologies for health financing in low-income and middle-income countries: a scoping review protocol

IntroductionUniversal health coverage (UHC) is a global priority, ensuring equitable access to quality healthcare services without financial hardship. Many countries face challenges in progressing towards UHC. Health financing is pivotal...

Exploring sexual and reproductive health among adolescent and young adult patients with cancer: A patient-oriented qualitative study using novel, serial focus groups.

e23080 Background: While treatment advances for adolescent and young adult (AYA, ages 15 - 39) cancers are improving survival, there is a lack of information and support regarding impacts of AYA cancer on sexual and reproductive health (SRH) during and after treatment. Our study explored SRH experiences of AYA cancer patients using novel, serial focus groups. Methods: With online and in-person approaches, we recruited folks who: 1) Were diagnosed with cancer at age 15 – 39; 2) Reside in Canada; and 3) Are over 18. Participants were grouped into cohorts based on akin characteristics (e.g., sex, stage). Each cohort engaged in three focus groups, mimicking support groups, to foster community and trust. An interview guide was iteratively developed with patient research partners. We used framework analysis to identify recurring themes and patterns, offering full insight of participants’ SRH perspectives and experiences from deductive and inductive views. Results: We recruited 4 focus group cohorts, with 6–10 participants each (N = 24 females, 6 males), representing various cancer types (e.g., pelvic, hematologic) and stages (1–4). Cohorts had representation of transgender (n = 1) and gender diverse folks (n = 3), non-heterosexual sexual orientation (n = 11), and racial diversity (n = 9). We identified three themes describing participants’ experiences: 1) internally (“looking inwards”) – impact of AYA cancer on SRH; 2) externally (“looking outwards”) – impact of cancer on interpersonal relationships; and 3) role of the healthcare system. Internally, folks described complex impacts of AYA cancer on themselves, revealing shifting definitions, perspectives, expectations, and goals of SRH over time. Dynamic interplays of AYA cancer also surfaced, unveiling mental, physical, and financial health changes that positively or negatively impacted participants’ SRH and influenced short and long-term well-being. Externally, changes in romantic relationships and family planning underscored the complex interplay of societal pressures on SRH and reproductive choices. Regarding the healthcare system, findings highlight facilitators (i.e., self-advocacy, nurses, recent pregnancy, provider with similar identity, etc.) and barriers (i.e., gender, SRH stigma, age, fertility treatment costs, heteronormativity, SRH deprioritization, etc.) that influence access to appropriate and available SRH resources and support. Conclusions: SRH challenges have significant internal and external impacts among AYA cancer patients and their interpersonal relationships during and after treatment. By understanding their SRH experiences throughout their cancer care, providers and the healthcare system can identify opportunities to implement SRH care more effectively into the cancer care continuum, significantly improving health outcomes for AYA cancer patients.

Leveraging Digitalization and Servitization to Improve Financial Performance: An Empirical Analysis

This research investigates the interplay between digitalization, servitization, and Corporate Social Responsibility (CSR) in influencing the financial performance of Pakistani banks. The study addresses a critical gap by examining how these factors combine to impact bank profitability in the contemporary landscape of digital transformation and evolving customer demands. A quantitative approach is employed, utilizing survey data collected from branch managers in Pakistani banks. Standardized scales measure digitalization, servitization, CSR, and bank performance. The findings demonstrate a positive direct effect of digitalization on bank performance. Furthermore, servitization strengthens this positive impact, suggesting that banks offering a comprehensive suite of services alongside traditional products achieve superior financial outcomes. Notably, the study reveals no significant short-term contribution of CSR to a bank's financial performance. Thus, the study sheds light on the crucial role of servitization in amplifying the positive effects of digitalization on bank performance. By strategically integrating services with products, banks can leverage digital technologies to become more data-driven and enhance their financial health.

Male breast cancer survival in Mexico between 2007 and 2016: A retrospective cohort.

1116 Background: Male breast cancer represents around 1% of all breast cancers worldwide. Due to its rarity, it is more likely to be diagnosed at advanced stages than in women, and survival rates tend to be lower than in female patients. Information about survival in male breast cancer in low- and middle-income countries (LMIC) is scarce. Methods: We conducted a retrospective cohort study cross-linking nationwide reimbursement claims for breast cancer cases between 2007 and 2016 treated within the Seguro Popular health financing scheme to a national mortality registry in Mexico. Age, municipality of residence, clinical stage, and year of treatment initiation were described. Facilities were classified according to location, total breast cancer patient volume, and type of funding. We estimated 5-year overall survival (OS) with 95% confidence intervals (95% CI) through the Kaplan Meier method and used the log-rank test to compare differences between patient groups. Patients with in situ disease and missing data for clinical stage were excluded from survival analyses. Results: We identified 268,703 claims representing 60,846 patients, from which 328 were male (0.53%). Median age was 56 years (IQR 48-67). At treatment initiation, 20.7% of patients had early disease, 46.3% had locally advanced (LA) disease and 15.5% metastatic disease; clinical stage information was missing in 16% of patients Most patients (86.6%) were treated at public facilities, and 40.5% were treated at high volume facilities. With a median follow-up of 4.1 years, five-year OS in the whole cohort was 64.3% (CI 95% 58.1-71.2). In patients with early-stage disease, 5-year OS was 78.7% (95% CI 67.0-92.4), in LA disease 66.3% (95% CI 58.4-75.3) and in metastatic disease 39.7% (95% CI 27.5-57.5) (p &lt;0.001). Patients with LA disease treated at a private facility had improved 5-year OS (88.9%) compared to those who were treated at a public facility (62.8%) (p=0.033). We did not find any other significant differences in survival according to patient or facility characteristics, including patient volume. Conclusions: These results represent the largest cohort to describe survival in men with breast cancer in Latin America. We found a larger proportion of men diagnosed with metastatic disease than described in women in Mexico, and lower than expected survival in patients with early-stage and LA disease.

Quantification of the environmental impact of radiotherapy and associated secondary human health effects: a multi-institutional retrospective analysis and simulation

The health-care industry is a substantial contributor to global greenhouse gas emissions, yet the specific environmental impact of radiotherapy, a cornerstone of cancer treatment, remains under-explored. We aimed to quantify the emissions associated with the delivery of radiotherapy in the USA and propose a framework for reducing the environmental impact of oncology care. In this multi-institutional retrospective analysis and simulation study, we conducted a lifecycle assessment of external beam radiotherapy (EBRT) for ten anatomical disease sites, adhering to the International Organization for Standardization's standards ISO 14040 and ISO 14044. We analysed retrospective data from Jan 1, 2017, to Oct 1, 2023, encompassing patient and staff travel, medical supplies, and equipment and building energy use associated with the use of EBRT at four academic institutions in the USA. The primary objective was to measure the environmental impacts across ten categories: greenhouse gases (expressed as kg of carbon dioxide equivalents [CO2e]), ozone depletion, smog formation, acidification, eutrophication, carcinogenic and non-carcinogenic potential, respiratory effects, fossil fuel depletion, and ecotoxicity. Human health effects secondary to these environmental impacts were also estimated as disability-adjusted life years. We also assessed the potential benefits of hypofractionated regimens for breast and genitourinary (ie, prostate and bladder) cancers on US greenhouse gas emissions using an analytic model based on the 2014 US National Cancer Database for fractionation patterns and patient commute distances. We estimated that the mean greenhouse gas emissions associated with a standard 25-fraction EBRT course were 4310 kg CO2e (SD 2910), which corresponded to 0·0035 disability-adjusted life years per treatment course. Transit and building energy usage accounted for 25·73% (1110 kg CO2e) and 73·95% of (3190 kg CO2e) of total greenhouse gas emissions, respectively, whereas supplies contributed only 0·32% (14 kg CO2e). Across the other environmental impact categories, most of the environmental impact also stemmed from patient transit and energy use within facilities, with little environmental impact contributed by supplies used. Hypofractionated treatment simulations suggested a substantial reduction in greenhouse gas emissions-by up to 42% for breast and 77% for genitourinary cancer-and environmental impacts more broadly. This comprehensive lifecycle assessment of EBRT delineates the environmental and secondary health impacts of radiotherapy, and underscores the urgent need for sustainable practices in oncology. The findings serve as a reference for future decarbonisation efforts in cancer care and show the potential environmental benefits of modifying treatment protocols (when clinical equipoise exists). They also highlight strategic opportunities to mitigate the ecological footprint in an era of escalating climate change and increasing cancer prevalence. Mount Zion Health Fund.

The single center experience with the war-related Ukrainian patients with various cancer diagnoses treated in clinical trials between 2022-2024.

e23040 Background: According to the WHO, 32% of active combat areas residents have been unable to obtain essential medicines since the beginning of the war in Ukraine. Clinical trials conducted in Poland have proven to assist oncological patients greatly. Many Ukrainian residents have Polish ancestors and are fluent in the Polish language. We decided to check whether the highest ethical standards of clinical trials make the ordinary intention to include a patient from Ukraine insufficient. Conducting a complete risk-benefit analysis allows choosing the best interest and safety of the clinical trial participant. Methods: The study aimed to evaluate the most frequent standards of oncological treatment of Ukrainian patients. We retrospectively verified the number of patients of Ukrainian nationality, in the age above 18 years treated at our center since the start of the invasion of Ukraine in February 2022 compared to the Polish patients. Results: Based on the National Health Fund data, Polish cancer centers in 2022 treated overall 994,767 patients including 8,000 patients from Ukraine. In the Pomeranian region, 3,815 patients received oncological therapies (data from the Central Statistical Office - of national). At our center in Gdansk between 01.01.2022 and 31.12.2023, therapy received 38,574 patients, including 34 Ukrainians. Clinical trials participants included 3,968 Polish and four Ukrainian patients (2 cases of malignant melanoma, one breast cancer, one lung cancer). Ukrainian patients represented 28.5%, 10%, and 8% of all patients included, respectively. Conclusions: Not prepared for the rapid influx of migrants Polish healthcare system encountered many problems like the language barrier, the need for a translator or approved documents by the Bioethics Committee, and the legal side of the informed consent form (ICF). At our center, all Ukrainian patients signed ICF in Polish. Regarding clinical trials participation, our study shows the unmet need of Ukrainian patients. The decision to include a patient has to be mutual (sponsor and investigator) and as soon as possible to ensure the required safety of each patient.