Elder Abuse And Neglect Research Articles

Self-Compassion and Emotion Dysregulation Mediate the Effect of Stress Appraisals on Elder Abuse and Neglect Behaviors in Dementia Family Caregiving.

The purpose of this paper is to evaluate the mechanistic process by which family caregivers' situational stress appraisals of behavioral symptoms of dementia (BSD) increase the likelihood of a caregiver engaging in abusive and neglectful behaviors toward their care recipient with dementia. We test the hypotheses that (1) the effect of daily BSD stress appraisals on elder abuse and neglect (EAN) is mediated by the caregivers' emotion dysregulation (2) and the mediation path is moderated by self-compassion. This study employed a multitime series design in which participants (N = 453) completed traditional longitudinal surveys at enrollment followed by 21 sequential days of diary surveys (n = 9,513). The hypothesized moderated mediation path was evaluated through a multilevel structural equation model. Hypotheses were supported. At the within-person level, daily BSD stress appraisal has a significant direct effect on daily EAN. At the between-person level, the path was no longer significant implying a full mediation of emotion dysregulation. The main effect of self-compassion and the interaction term (emotion dysregulation × self-compassion) were also statistically significant indicating the path between emotion dysregulation and EAN is moderated by self-compassion. This study significantly advances the field by empirically showing a mechanistic pathway for a theoretical explanation of EAN. These findings represent a breakthrough for the field and identify modifiable intervention targets for future behavioral interventions to prevent EAN. Emotion (dys)regulation and self-compassion are modifiable traits and skills that can be learned, with robust evidence bases of efficacious interventions that can be adapted for context to dementia family caregiving.

Outcomes of elder abuse and neglect in Central Europe: exploring the link between EAN and well-being among non-institutionalized older adults

ABSTRACT Informed by existing gaps in the research of elder abuse and neglect (EAN) outcomes and very limited knowledge from Central-European cultural contexts, this paper analyzes the link between domestic-based EAN and three measures of well-being, namely subjective loneliness, sense of control over one’s life, and a broader outlook on life. To do this, we used recently (2022) collected EAN survey fielded among home-dwelling residents of the Czech Republic aged 65 + . The results show that there is a clear relationship between EAN and these selected outcomes. Controlling for several sets of potential modifying or confounding factors further indicates that this relationship is substantial and direct, rather than weak and indirect. Among controls, only variables related to disadvantage (health, income, dependency, history of abuse) partly account for the link between EAN and its outcomes due to their relation to both heightened risk of EAN and lower well-being.

DYNAMIC IMPACTS OF FAMILY CONFLICT ON ELDER ABUSE AND NEGLECT AMONG ADRD CAREGIVERS

Abstract Conflict with other family members impacts dementia caregivers’ well-being and stress-appraisals and may also influence their use of elder abuse and neglect (EAN). To test this, we utilized latent class analysis to classify spouse, adult child, grandchild, and nontraditional (step- and in-laws) caregivers (N = 453) based on family conflict levels at baseline. Caregivers were classified into four groups: “low,” “moderate,” “high,” and “EAN accusations.” Spouses were significantly more likely to be in the “low” class compared to other classes. Nontraditional caregivers were more likely to be in the “EAN accusations” class versus the “moderate” class (β = 1.73, SE = .70, p < .05). Belonging to the EAN accusations class predicted EAN at baseline (t = 3.728, p < .001). Next, dynamic structural equation modeling was used to test whether stress from family conflict on a given day predicts use of EAN behaviors. Family conflict stress predicted EAN on the same day (β = 0.05, 95% CI = 0.03-0.07), but not the subsequent day (CL= -0.01, 95% CI = 0.03-0.02). Similar models were conducted for each relationship type. The effect of family conflict stress on EAN was not significant for spouse and grandchildren but remained significant for adult child and non-traditional caregivers. Findings suggest interventions related to conflict management and communication among caregiving families may be beneficial new intervention targets for reducing EAN in ADRD. Addressing family conflict may be most important when the caregiver is an adult child or nontraditional relationship.

ALCOHOL CONSUMPTION AND ABUSIVE/NEGLECTFUL BEHAVIORS AMONG FAMILY CAREGIVERS OF PEOPLE LIVING WITH DEMENTIA

Abstract Despite its suspected role in elder abuse and neglect (EAN), little is known about alcohol use disorders (AUD) among family caregivers of people with Alzheimer’s disease and related dementia (ADRD). As part of a micro-longitudinal study in which caregivers completed 21 daily surveys about their caregiving experiences, we examined the effects of daily drinking behaviors and screening positive for hazardous drinking (based on the Alcohol Use Disorder Identification Test (AUDIT-C)) on the daily risk of EAN. A generalized linear mixed model with days (n = 9513) nested within caregivers (N=453) was used to evaluate the relationships between caregivers’ alcohol consumption patterns and the odds of using an abusive and/or neglectful behavior. Caregivers’ alcohol consumption on a given day increases the odds of using physical abuse (OR=2.19; 95% CI=1.12–4.28; p=.022), psychological abuse (OR=1.40; 95% CI=1.01–1.94; p=.041) and neglect (OR=1.48; 95% CI=1.17–1.86; p=.001) that same day. Screening positive for AUD significantly increases the odds of a caregiver’s use of neglect on a given day (OR=2.43, 95% CI=1.52–3.88, p=<.001), but not physical or psychological abuse. There were no interaction effects between AUD and daily drinking, meaning AUD increases the risk of neglect independent of daily drinking behavior. Interventions to manage AUD may reduce the risk of neglect among ADRD caregivers experiencing hazardous drinking. Interventions focused on daily drinking behaviors are needed to reduce the general risk of EAN among ADRD caregivers. Findings show that subpopulations exist within ADRD caregivers who engage in EAN behaviors that would benefit from different targeted interventions.

A community engaged exploratory study investigating the risk of elder abuse and neglect in two refugee communities in Greensboro, North Carolina

ABSTRACT Elder abuse and neglect (EAN) are serious health and human rights issues. Less is known about EAN in refugee communities. University researchers and leaders of a refugee services nonprofit partnered to conduct an exploratory community engaged study on EAN risks in two refugee communities in North Carolina. A convenience sample of 17 Nepali-speaking Bhutanese and 13 Congolese self-identified older adults filled short surveys and participated in Focus Group Discussions (FGDs). Descriptive survey findings showed EAN risk, isolation, economic insecurity, and family dependency, more among Congolese. FGDs yielded no reports of EAN, but showed dependence on family, and difficulties with language, transportation, and economic insecurity in both groups. These factors indicate individual and contextual vulnerabilities for EAN in these communities. An EAN awareness event was conducted for participants by a family violence nonprofit. Refugee older adults need culturally appropriate coordinated services including EAN information, English classes, job skills, income, and transportation.

Mortality of elder financial and psychological abuse victims in rural Malaysia: a prospective cohort study

ObjectivesTo determine the longitudinal impact of elder financial and psychological abuse on risk of death among older Malaysians.Design7-year prospective cohort study. Baseline data were collected in late 2013 and respondents...

Elder abuse and hospitalization in rural Malaysia.

Our study aims to describe and determine factors associated with hospitalization among victims of elder abuse and neglect (EAN) in rural Malaysia. A cross sectional study based on the baseline data of the Malaysian Elder Mistreatment Project (MAESTRO) collected from November 2013 until July 2014 involving 1927 older adults in Kuala Pilah, Negeri Sembilan was conducted. EAN was determined using the modified Conflict Tactics Scale (CTS) and hospitalization rates were determined based on self-report. The prevalence of overall EAN was 8.1% (95%CI 6.9–9.3). Among male respondents, 9.5% revealed history of abuse and among female respondents, 7.2% reported experiencing EAN. The annual hospitalization rates per 100 persons within the past one year among EAN victims and non-victims were 18 per 100 persons (SD = 46.1) and 15 per 100 persons (SD = 64.1) respectively. Among respondents with history of EAN, 16.0% (n = 21) had been hospitalized in the past 12 months while among respondents with no EAN experience, 10.2% (n = 153) were hospitalized. Multivariable analyses using Poisson regression did not show any significant association between EAN and hospitalization. This could be due to the complex interactions between medical and social circumstances that play a role in hospital admissions, factors affecting the health care system, and access to health care among EAN victims.

Early Stages of COVID-19 Pandemic Had No Discernable Impact on Risk of Elder Abuse and Neglect Among Dementia Family Caregivers: A Daily Diary Study.

There is widespread concern that elder abuse and neglect (EAN) incidents increased during the onset of the COVID-19 pandemic due in part to increases in risk factors. Initial reports relying on administrative systems such as adult protective services records produced mixed results regarding whether or not there was a change in EAN incidents. Using data from an ongoing longitudinal study on EAN in dementia family caregiving that started before the pandemic, we assessed the hypothesis that the pandemic is related to a change in probability of EAN and EAN protective factors. Family caregivers to persons with dementia completed two waves of 21 daily diaries, 6-months apart, assessing their daily use of EAN behaviors. The first group (n = 32) completed their first wave before the pandemic and their second wave during the pandemic. The second group (n = 32) completed both waves during the pandemic. For this cohort, the generalized linear mixed logistic model results showed inconsistent associations between the onset of COVID-19 and the probability of a caregiver engaging in elder abuse or neglect behaviors. In terms of protective factors, the use of formal services was not significantly impacted by COVID-19; however, the likelihood of receiving informal support from family and friends increased significantly during the pandemic period. Dementia family caregivers were not likely impacted negatively by initial pandemic restrictions, such as shelter-in-place orders, as anticipated. These findings contribute to our understanding of how distal, disruptive processes may influence more proximal caregiver stresses and the likelihood of EAN.Supplementary InformationThe online version contains supplementary material available at 10.1007/s10896-022-00392-8.

Malay version of the modified Conflict Tactics Scale of elder abuse and neglect (MMCTS-EAN): Validation and methodological challenges

ABSTRACT Among the challenges in systematic inquiry into elder abuse and neglect (EAN) is the lack of standardized tool of measurement. Existing literature demonstrates diverse tools being used, with the Conflict Tactics Scale (CTS) and its versions being the most common. The Malaysian Elder Mistreatment Project (MAESTRO) utilized the Modified CTS developed and used by the National Study of Elder Abuse and Neglect in Ireland (NSEA-I). This article aimed to validate this Malay version of the modified CTS for use in the Malaysian context and by Malay-speaking populations across Southeast Asia while highlighting the various practical and methodological challenges encountered along the process. Data were collected from 1927 older respondents who lived in Kuala Pilah district. Preliminary data screening led to the dropping of 10 items due to 0 variance. Further four items were deleted during CFA due to low loading. The indicators of neglect factor were made into a composite factor due to high collinearity. The final scale had acceptable reliability and validity. This tool is likely to assist in assessing and detecting EAN more quickly and conveniently. It will also assist future researches of EAN in taking into account the issues that arise in the measurement of EAN.

Sensitizing Family Caregivers to Influence Treatment Compliance among Elderly Neglected Patients-A 2-Year Longitudinal Study Outcome in Completely Edentulous Patients.

Healthcare workers have reported a certain segment of geriatric patients that are suffering from abuse/neglect, which in turn has been associated with anxiety, depression, and helplessness in the individual. Family caregivers (blood relations), being the most common perpetrators of elder abuse and neglect (EAN), have also been shown to respond to sensitization if the type of EAN and the interventions are appropriate. This study was aimed to comparatively analyze the influence of intervention (psychotherapeutic sensitization of FCG) upon long-term (24 months) treatment maintenance and satisfaction in elderly neglected patients. One hundred and fifty patients (aged 41–80 years) suffering from elder neglect (EN) (self-confession) and their respective FCGs, fulfilling the study criteria, participated in this longitudinal 2-year study. The patients were randomly distributed (simple random, convenient) in two equal groups (75 each), namely Group (GP) A (control) and GP B (test). A standardized, complete denture treatment was initiated for all the participants. Both the FCGs and the patients of GP B were sensitized (psychotherapeutic education) for EN, while there was no such intervention in GP A. The influence of such intervention was measured for denture maintenance [denture plaque index (DPI) scores] and treatment satisfaction (10-point visual analog scale). Absolute/relative frequencies and means were major calculations during data analysis. Differences between the groups for any treatment compliance parameter was done through the unpaired t-test, while Karl Pearson’s test determined the level of relationship between variables (p-value < 0.05). Decrease in mean DPI scores (suggesting improvement) was seen among patients in GP A from 1 month (m = 2.92) to 24 months (m = 2.77). A negligible increase in DPI scores was observed among patients of GP B from 1 month (m = 1.38) to 24 months (m = 1.44). Differences in mean values between the two groups were statistically significant at 24-month intervals, while the relationship between the variables was nonsignificant. FCG sensitization through psychotherapeutic education shows a long-term positive influence on the treatment compliance (maintenance and satisfaction). Identifying the existence of EAN among geriatric patients, followed by psychotherapeutic education of FCGs is recommended for routine medical and dental long-duration treatment procedures.

Use of video vignettes and case discussions to educate health professions students about elder abuse

Video vignettes depicting the care of an older patient were created to improve student understanding of elder abuse and neglect (EAN). Four hundred and eight students from five health professions programs participated in this interprofessional education (IPE) activity. The main objective of the IPE activity was to improve student understanding of EAN issues and to facilitate interprofessional discussion focused on recognition of and reaction to EAN in the healthcare setting. Students received three video vignettes ahead of time and were asked to list all their concerns regarding the management of the patient (pre-activity). One week later, students completed the Caregiving Scenario Questionnaire (CSQ) and a knowledge survey measuring student knowledge regarding EAN. Students then attended a 4-h IPE event focusing on team discussion of EAN issues. Interprofessional teams watched three different vignettes and once again listed their concerns regarding the care of the patient depicted in the videos (in-class activity). Two weeks after the event, individual students completed the CSQ, the knowledge survey, and an event survey evaluating the IPE event and student attitudes regarding scope of practice knowledge (post-activity). On the pre-activity, the percentage of students correctly identifying EAN ranged from 39% to 70%. On the in-class activity, the percentage of teams correctly identifying EAN ranged from 57% to 91%. On the post-activity, significant improvements were noted in student ability to recognize “abusive” actions on the CSQ with seven of the thirteen improving significantly. However, for “potentially abusive”, and “not abusive” behaviors, students were less likely to list those correctly. Statistically significant improvement was noted on all items in the knowledge survey. On the event survey, majority of students rated the various facets of the IPE event as ‘beneficial’ or ‘very beneficial’. Overall, this IPE event appeared to improve student understanding of issues related to EAN and could be replicated by other programs.

The under-reporting of elder abuse and neglect: a Malaysian perspective

ABSTRACT This commentary highlights the issue of under-reporting of elder abuse and neglect (EAN) in the Malaysian context. It attempts to elucidate the findings of the 2018 National Health and Morbidity Survey (NHMS) related to the trend of reporting among EAN victims, and offer some recommendations.

Impact of Sensitization of Family Caregivers upon Treatment Compliance among Geriatric Patients Suffering from Elder Abuse and Neglect.

Geriatric patients in various outpatient department (OPDs) have been found to agonize from elder abuse and neglect (EAN). Such suffering imposes depressive states within individuals, which in turn affects treatment compliance. The objective of this study was to evaluate the impact of sensitization (psychotherapeutic) of family caregivers (FCGs) upon two denture treatment parameters (maintenance and treatment satisfaction) among EAN patients and compare the differences in outcome with non-abused patients. A survey of completely edentulous subjects (n = 860, aged 41–80 years) provided a sampling frame of 332 EAN patients from which 150 patients (including FCGs) fulfilling the study criteria were distributed (simple random, convenient) into two groups (Group A—control, Group B—test). FCG sensitization for subjects in Group B was performed by a clinical psychologist in 2–4 short (30 min) sessions. Demographic characteristics (frequency) were measured using a self-reported questionnaire, denture maintenance was measured using a denture hygiene index (scores), and treatment satisfaction was analyzed on a 10-point visual analog scale. Relevant data were calculated for means and absolute/relative frequencies. Any difference between two groups was estimated using an unpaired t-test while the level of relationship was determined by Karl Pearson’s test at a p-value of < 0.05. The results showed highest frequency (38.6%) for neglect, with elder neglect (EN) being most common (38.14% alone and 14% in combination). EN was found more if the FCG was a son (52%), in the age group (21–30 years), and with low education and low income (75%). Patients whose FCGs were counselled (Group B) demonstrated low denture plaque scores (mean = 1.38 ± 0.618), while demonstrating comparatively higher scores in six different parameters of treatment satisfaction. Differences between the two groups for both parameters were also found to be statistically significant. Psychotherapeutic counselling in the form of FCG sensitization brings better results of denture maintenance and treatment satisfaction.

Daily stressful experiences, depressive symptoms, and behavioral responses of ADRD family caregivers

AbstractBackgroundFamily caregivers of individuals living with Alzheimer’s disease or related dementias (ADRDs) are at a higher risk for serious mental illness, specifically depression. Caring for individuals living with ADRDs can be stressful due to the behavioral symptoms of dementia (BSD). Over time, stressors, such as BSDs, can contribute to the onset of depressive symptoms. Few studies have examined BSDs as contextual triggers contributing to variations in daily mental health symptom experiences of caregivers. Further, it is unclear how behavioral adaptations to caregiving‐specific stressors, such as engaging in elder abuse and neglect (EAN), impact caregiver mental health. In this study, we identified specific individual vulnerabilities, daily environmental stressors, and caregiver behaviors that increase the daily odds of experiencing depressive symptoms.MethodUsing a micro‐longitudinal design and ecological momentary assessment methods, we examined daily environmental stressors (BSDs), caregiver behaviors (i.e., EAN events), and individual vulnerabilities (i.e., demographics, early life adversity, social isolation, social support, and coping strategies) that impact daily odds of experiencing depressive symptoms. Data were collected from a national sample of family caregivers (N=50) who completed daily diaries over a 21‐day period (n=841). Multi‐level modeling was used to test a series of hypotheses on the relationship between daily environmental stressors, caregiver behaviors, individual vulnerabilities, and depression symptom experiences.ResultFamily caregivers were more likely to report depressive symptoms on a given day when a BSD was present and perceived as bothersome (OR = 1.22, 95% CI: 1.09‐1.43, p = 0.002). Additionally, when an EAN event occurred on a given day, caregivers were more likely to report depressive symptoms (OR = 1.27, 95% CI: 1.02‐1.58, p = 0.034) . Individual‐level factors also interacted with BSD, EAN events, and daily depressive symptoms.ConclusionThe results from this study help elucidate factors that contribute to variations in the daily mental health symptom experiences of ADRD caregivers. The interactions between BSDs, EAN events, and depression identified in this study will inform interventions to better support family caregivers and improve mental health outcomes for an at‐risk population.

Evaluating the Effectiveness of I-NEED Program: Improving Nurses’ Detection and Management of Elder Abuse and Neglect—A 6-Month Prospective Study

Elder abuse and neglect (EAN) goes largely unrecognized and underreported globally by health care professionals. Despite acknowledging their role to intervene elder abuse, health care professionals lacked knowledge and skills in this issue. This is a single-blinded, three-armed, cluster randomized controlled trials aimed to evaluate the effectiveness of the face-to-face Improving Nurses' dEtection and managEment of elDer abuse and neglect (I-NEED) intensive training program and I-NEED educational video in improving primary care nurses' knowledge, attitude, and confidence to intervene EAN; 390 primary care nurses were randomized equally into two intervention groups-ITP group (intensive training program) and ITP+ group (intensive training program and educational video)-and a control group. The knowledge, attitudes, and confidence to intervene EAN were measured using questionnaires at four intervals during 6-month follow-up. A total of 269 primary care nurses participated in this study. There was a significant increase in knowledge, attitude, and confidence to intervene EAN immediately post intervention observed in both intervention groups compared to the control group (p < .001). At the end of sixth month, there was an increase of knowledge favoring ITP group than the ITP+ group (p < .001). There is, however, no significant difference in attitude score between ITP and ITP+ group. There is a significant difference of confidence to intervene among the participants between both intervention groups with ITP+ participants reporting higher scores post intervention (p < .05). An intensive training module improved the knowledge, attitude, and confidence to intervene EAN. Other co-existing barriers for abuse victims getting help, resources, policy, and law of EAN need further highlights.

CO-OCCURRENCE OF ABUSE AND NEGLECT AS REPORTED BY DEMENTIA FAMILY CAREGIVERS

Understanding the co-occurrence or overlap among multiple forms of elder abuse and neglect (EAN) is important for designing effective interventions. This paper reports patterns of family caregiver’s daily behaviors related to physical assault, psychological mistreatment, and neglect. Majority of participants self-reported at least one EAN behavior (74%), with most reporting using multiple forms of EAN over the 21-day period (52%). On a given day, psychological mistreatment and neglect were more likely to happen in isolation, while physical assault was more likely to co-occur with psychological mistreatment. The mixed model’s intra-class coefficient suggests the daily context, rather than personal characteristics, explain the variance in the use of EAN. These findings highlight the importance of never minimizing a single event of EAN reported in clinical practice, give the high rate of polyvictimization, and reinforces the need to understand why caregivers use one form of EAN over another on a given day.

RISK AND PROTECTIVE FACTORS FOR ABUSE AND NEGLECT IN DAILY CAREGIVING

The stress-process model suggests a variety of factors related to the stress-experience as important in the formation of outcomes including elder abuse and neglect (EAN). Multi-level modeling with days (n=831) nested within caregivers (N=50) was used to evaluate relationships between theoretically-based risk and protective factors and odds of EAN. Disruptions in the daily routine are a significant risk factor for abuse and neglect. Participating in a meaningful activity at least twice a day with the care recipient is a significant protective factor for neglect (OR=0.19; CI=0.06-0.64; p=0.01), but not abuse. Hypotheses that spending the full day together would increase the risk of EAN, and receipt of instrumental support and caregiver participation in self-care would decrease risk, were not supported. Findings demonstrate that the risk of EAN varies from day-to-day in the presence and absence of contextual factors. Moreover, abuse and neglect may have different etiologic pathways.

ELDER ABUSE AND NEGLECT IN URBAN AND RURAL AREAS IN CHINA: PREVENTION STRATEGIES

With acceleration of the ageing population globally, more and more governments are concerned about the potential increase in elder abuse and neglect (EA/N). Recently the National Office for Ageing and the provincial offices for ageing conducted a survey of 224,352 Chinese over the age of 60 years using household interviews to assess economy, health, service, social participation, culture, rights protection, livable environment, etc. Author’s analysis of this data shows that 54% of the elderly people interviewed experienced physical and mental abuse or intimidation, and 6.95% of them felt that their legal rights were violated. Data also supports that the occurrence of EA/N was significantly correlated to self-care ability, economic status, and urban and rural regions of the elders. The researcher will discuss the practice and policy implications for the prevention of EA/N.

Does abuse in late life worsen sleep quality? A two-year prospective cohort study among rural older adults.

Elder abuse and neglect (EAN) is a growing public health problem, and numerous adverse health effects of abuse in late life have been documented. Little is known, however, about the impact of elder abuse on sleep quality. This study examines the longitudinal relationship between EAN and sleep quality. This was a 2-year prospective cohort study involving 1927 older adults in a rural Malaysian district, Kuala Pilah. A multi-stage cluster sampling strategy was employed. After 2years, 1189 respondents were re-assessed. EAN was determined using the modified Conflict Tactic Scale, while sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI). The prevalence of elder abuse was 8.1% (95% CI:6.9,9.3). Longitudinal analysis using generalized estimating equations showed that elder abuse contributed to higher PSQI scores (B:0.49, 95% CI:0.17,0.58). Sub-analyses demonstrated that psychological abuse and neglect had significant longitudinal relationships with increase of PSQI scores, while other subtypes did not. Abuse in late life, particularly psychological abuse and neglect, result in greater PSQI scores. Even though this may imply decline in sleep quality, our findings were not considered clinically significant as they did not exceed the clinical cut-off score of five. Nevertheless, sleep quality is an important determinant of health and a predictor of mortality among older adults; thus, understanding its relationship with abuse is useful to health care providers and policy-makers in improving health services and upgrading preventive measures.

Recruitment, enrollment & data collection with victims of elder abuse and neglect identified from police incident reports

ABSTRACTThis study evaluated the success of researcher-generated recruitment, enrollment, data collection, and safety protocols for field research with victims of elder abuse and neglect (EAN) identified from police incident reports in terms of their success including cost-effectiveness, ability to generate a representative sample, and safety. After reviewing 492 police incident reports involving victims age 65 years or older to identify cases of EAN 62 victims were identified. Mail, phone, and in-person recruitment strategies were used. After 259 recruitment attempts, 52 (84%) eligible victims were contacted, of which 24 (46%) consented to participate. Phone calls were the least expensive mechanism to produce a successfully enrolled participant. Findings from a regression show completion of a research interview could not be predicted by victim, suspect, or offense characteristics, indicating that the recruited victims likely represent the population they were drawn from. No safety or adverse events occurred.