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Economic activity is more globally integrated than ever before, but so is the scope of corporate misconduct. As more and more people across the world are affected by such malfeasance, the differences in legal redress have become increasingly visible. This transparency has resulted in a growing convergence towards an American model of robust private enforcement of the law, including the class-action lawsuit. This handbook brings together scholars from nearly two dozen countries to describe and assess the class-action procedure (or its equivalent) in their respective countries and, where possible, to offer empirical data on these systems. At the same time, the work presents a variety of multidisciplinary perspectives on class actions, from economics to philosophy, making this handbook an essential resource to academics, lawyers, and policymakers alike.
Recently published diagnostic criteria for mild cognitive impairment with Lewy bodies (MCI-LB) include five neuropsychiatric supportive features (non-visual hallucinations, systematised delusions, apathy, anxiety and depression). We have previously demonstrated that the presence of two or more of these symptoms differentiates MCI-LB from MCI due to Alzheimer's disease (MCI-AD) with a likelihood ratio >4. The aim of this study was to replicate the findings in an independent cohort.
Participants ⩾60 years old with MCI were recruited. Each participant had a detailed clinical, cognitive and imaging assessment including FP-CIT SPECT and cardiac MIBG. The presence of neuropsychiatric supportive symptoms was determined using the Neuropsychiatric Inventory (NPI). Participants were classified as MCI-AD, possible MCI-LB and probable MCI-LB based on current diagnostic criteria. Participants with possible MCI-LB were excluded from further analysis.
Probable MCI-LB (n = 28) had higher NPI total and distress scores than MCI-AD (n = 30). In total, 59% of MCI-LB had two or more neuropsychiatric supportive symptoms compared with 9% of MCI-AD (likelihood ratio 6.5, p < 0.001). MCI-LB participants also had a significantly greater delayed recall and a lower Trails A:Trails B ratio than MCI-AD.
MCI-LB is associated with significantly greater neuropsychiatric symptoms than MCI-AD. The presence of two or more neuropsychiatric supportive symptoms as defined by MCI-LB diagnostic criteria is highly specific and moderately sensitive for a diagnosis of MCI-LB. The cognitive profile of MCI-LB differs from MCI-AD, with greater executive and lesser memory impairment, but these differences are not sufficient to differentiate MCI-LB from MCI-AD.
The emphasis on team science in clinical and translational research increases the importance of collaborative biostatisticians (CBs) in healthcare. Adequate training and development of CBs ensure appropriate conduct of robust and meaningful research and, therefore, should be considered as a high-priority focus for biostatistics groups. Comprehensive training enhances clinical and translational research by facilitating more productive and efficient collaborations. While many graduate programs in Biostatistics and Epidemiology include training in research collaboration, it is often limited in scope and duration. Therefore, additional training is often required once a CB is hired into a full-time position. This article presents a comprehensive CB training strategy that can be adapted to any collaborative biostatistics group. This strategy follows a roadmap of the biostatistics collaboration process, which is also presented. A TIE approach (Teach the necessary skills, monitor the Implementation of these skills, and Evaluate the proficiency of these skills) was developed to support the adoption of key principles. The training strategy also incorporates a “train the trainer” approach to enable CBs who have successfully completed training to train new staff or faculty.
Sleep deprivation is common among both college students and athletes and has been correlated with negative health outcomes, including worse cognition. As such, the current study sought to examine the relationship between sleep difficulties and self-reported symptoms and objective neuropsychological performance at baseline and post-concussion in collegiate athletes.
Seven hundred seventy-two collegiate athletes completed a comprehensive neuropsychological test battery at baseline and/or post-concussion. Athletes were separated into two groups based on the amount of sleep the night prior to testing. The sleep duration cutoffs for these group were empirically determined by sample mean and standard deviation (M = 7.07, SD = 1.29).
Compared with athletes getting sufficient sleep, those getting insufficient sleep the night prior to baseline reported significantly more overall symptoms and more symptoms from each of the five symptom clusters of the Post-Concussion Symptom Scale. However, there were no significant differences on objective performance indices. Secondly, there were no significant differences on any of the outcome measures, except for sleep symptoms and headache, between athletes getting insufficient sleep at baseline and those getting sufficient sleep post-concussion.
Overall, the effect of insufficient sleep at baseline can make an athlete appear similar to a concussed athlete with sufficient sleep. As such, athletes completing a baseline assessment following insufficient sleep could be underperforming cognitively and reporting elevated symptoms that would skew post-concussion comparisons. Therefore, there may need to be consideration of prior night’s sleep when determining whether a baseline can be used as a valid comparison.
Although several initiatives have produced core competency domains for training the translational science workforce, training resources to help clinical research professionals advance these skills reside primarily within local departments or institutions. The Development, Implementation, and AssessMent of Novel Training in Domain (DIAMOND) project was designed to make this training more readily and publicly available. DIAMOND includes a digital portal to catalog publicly available educational resources and an ePortfolio to document professional development. DIAMOND is a nationally crowdsourced, federated, online catalog providing a platform for practitioners to find and share training and assessment materials. Contributors can share their own educational materials using a simple intake form that creates an electronic record; the portal enables users to browse or search this catalog of digital records and access the resources. Since September 2018, the portal has been visited more than 5,700 times and received over 280 contributions from professionals. The portal facilitates opportunities to connect and collaborate regarding future applications of these resources. Consequently, growing the collection and increasing numbers of both contributors and users remains a priority. Results from a small subset of users indicated over half accomplished their purpose for visiting the site, while qualitative results showed that users identified several benefits and helpful features of the ePortfolio.
In response to advancing clinical practice guidelines regarding concussion management, service members, like athletes, complete a baseline assessment prior to participating in high-risk activities. While several studies have established test stability in athletes, no investigation to date has examined the stability of baseline assessment scores in military cadets. The objective of this study was to assess the test–retest reliability of a baseline concussion test battery in cadets at U.S. Service Academies.
All cadets participating in the Concussion Assessment, Research, and Education (CARE) Consortium investigation completed a standard baseline battery that included memory, balance, symptom, and neurocognitive assessments. Annual baseline testing was completed during the first 3 years of the study. A two-way mixed-model analysis of variance (intraclass correlation coefficent (ICC)3,1) and Kappa statistics were used to assess the stability of the metrics at 1-year and 2-year time intervals.
ICC values for the 1-year test interval ranged from 0.28 to 0.67 and from 0.15 to 0.57 for the 2-year interval. Kappa values ranged from 0.16 to 0.21 for the 1-year interval and from 0.29 to 0.31 for the 2-year test interval. Across all measures, the observed effects were small, ranging from 0.01 to 0.44.
This investigation noted less than optimal reliability for the most common concussion baseline assessments. While none of the assessments met or exceeded the accepted clinical threshold, the effect sizes were relatively small suggesting an overlap in performance from year-to-year. As such, baseline assessments beyond the initial evaluation in cadets are not essential but could aid concussion diagnosis.
Lewy body dementia, consisting of both dementia with Lewy bodies (DLB) and Parkinson's disease dementia (PDD), is considerably under-recognised clinically compared with its frequency in autopsy series.
This study investigated the clinical diagnostic pathways of patients with Lewy body dementia to assess if difficulties in diagnosis may be contributing to these differences.
We reviewed the medical notes of 74 people with DLB and 72 with non-DLB dementia matched for age, gender and cognitive performance, together with 38 people with PDD and 35 with Parkinson's disease, matched for age and gender, from two geographically distinct UK regions.
The cases of individuals with DLB took longer to reach a final diagnosis (1.2 v. 0.6 years, P = 0.017), underwent more scans (1.7 v. 1.2, P = 0.002) and had more alternative prior diagnoses (0.8 v. 0.4, P = 0.002), than the cases of those with non-DLB dementia. Individuals diagnosed in one region of the UK had significantly more core features (2.1 v. 1.5, P = 0.007) than those in the other region, and were less likely to have dopamine transporter imaging (P < 0.001). For patients with PDD, more than 1.4 years prior to receiving a dementia diagnosis: 46% (12 of 26) had documented impaired activities of daily living because of cognitive impairment, 57% (16 of 28) had cognitive impairment in multiple domains, with 38% (6 of 16) having both, and 39% (9 of 23) already receiving anti-dementia drugs.
Our results show the pathway to diagnosis of DLB is longer and more complex than for non-DLB dementia. There were also marked differences between regions in the thresholds clinicians adopt for diagnosing DLB and also in the use of dopamine transporter imaging. For PDD, a diagnosis of dementia was delayed well beyond symptom onset and even treatment.
Commercialization of 2,4-D–tolerant crops is a major concern for sweetpotato producers because of potential 2,4-D drift that can cause severe crop injury and yield reduction. A field study was initiated in 2014 and repeated in 2015 to assess impacts of reduced rates of 2,4-D, glyphosate, or a combination of 2,4-D with glyphosate on sweetpotato. In one study, 2,4-D and glyphosate were applied alone and in combination at 1/10, 1/100, 1/250, 1/500, 1/750, and 1/1,000 of anticipated field use rates (1.05 kg ha−1 for 2,4-D and 1.12 kg ha−1 for glyphosate) to ‘Beauregard’ sweetpotato at storage root formation (10 days after transplanting [DAP]). In a separate study, all these treatments were applied to ‘Beauregard’ sweetpotato at storage root development (30 DAP). Injury with 2,4-D alone or in combination with glyphosate was generally equal or greater than with glyphosate applied alone at equivalent herbicide rates, indicating that injury is attributable mostly to 2,4-D in the combination. There was a quadratic increase in crop injury and quadratic decrease in crop yield (with respect to most yield grades) with increased rate of 2,4-D applied alone or in combination with glyphosate applied at storage root development. However, neither the results of this relationship nor of the significance of herbicide rate were observed on crop injury or sweetpotato yield when herbicide application occurred at storage root formation, with a few exceptions. In general, crop injury and yield reduction were greatest at the highest rate (1/10×) of 2,4-D applied alone or in combination with glyphosate, although injury observed at lower rates was also a concern after initial observation by sweetpotato producers. However, in some cases, yield reduction of U.S. no.1 and marketable grades was also observed after application of 1/250×, 1/100×, or 1/10× rates of 2,4-D alone or with glyphosate when applied at storage root development.
Antimicrobial stewardship of anti-infectives prescribed upon hospital discharge was implemented to improve the rate of appropriate prescribing at discharge. Appropriate prescribing significantly improved from 47.5% to 85.2% (P < .001), antimicrobial days of therapy decreased, and 30-day readmission rates decreased. Discharge antimicrobial stewardship was effective in improving anti-infective prescribing practices.
OBJECTIVES/GOALS: This study’s goal is to examine the feasibility and acceptability of using VRM to impact the APP of adults in the inpatient setting. Aims include examining the: 1) feasibility of VRM for APP management; 2) acceptability of using VRM for APP management; and 3) experience of VRM for APP management. METHODS/STUDY POPULATION: To comprehensively examine participants’ experience of using VRM for APP, this study will employ a convergent mixed-methods design in which living kidney donors (N = 45) will be recruited to serially use VRM during their hospital stay. Feasibility and acceptability will be evaluated using descriptive and inferential statistics evaluating patient-reported outcome (PRO) measures taken pre-, post- and 1-hour post-VRM, PRO measures extracted from the participant’s electronic health record and data on VRM use. Semi-structured interviews will allow formulation of inferences based on participants’ experience of VRM for APP management and their insights on content, deployment, and clinical use of VRM. RESULTS/ANTICIPATED RESULTS: This in-process study expects: 1) an adequate sample of participants undergoing living kidney donor surgery who agree to enroll with retention of >90% of participants (Aim 1); 2) participants to report VRM as an acceptable and suitable treatment, feel “present” and interested in the VR environment, and feel comfortable using VRM in the hospital (Aim 2); and 3) to provide insight into participants’ experience of VRM for APP, understanding of extended VRM use for APP analgesia, examination of key variables affecting participants’ experience of VRM for APP and feedback about VRM procedures and protocol to inform future VRM use for APP management (Aim 3). DISCUSSION/SIGNIFICANCE OF IMPACT: Results of the proposed study will inform future clinical testing and deployment of VRM, guide future use of VRM as an adjunct for inpatient APP management, and provide insight into inpatients’ experience of VRM for APP analgesia.
OBJECTIVES/GOALS: Early age at menopause has been linked to increased risk of cardiovascular disease; however, there is limited evidence for a relationship between early menopause and heart failure (HF). We examined whether early menopause is associated with incident HF among women in the southeastern United States. METHODS/STUDY POPULATION: The Southern Community Cohort Study enrolled ~86,000 low-income black and white adults from 2002 to 2009. Participants for this analysis were 11,948 women who were postmenopausal at enrollment, had no history of HF, and were on Medicaid or Medicare. HF events were ascertained using ICD-9 codes 428.x via linkage of the cohort with CMS Research Identifiable Files through December 31, 2010. Early menopause was defined as self-reported age at menopause less than 45 years. Hazard ratios (HRs) and 95% confidence intervals (CIs) were computed from multivariable Cox regression models, overall and by race, adjusting for demographic, lifestyle, and reproductive factors, including reason for menopause. RESULTS/ANTICIPATED RESULTS: At baseline, mean age was 58±9 years, and 65% of participants were black. Among women with early menopause, 76% (n = 4,836) had menopause due to hysterectomy or oophorectomy. In women with later menopause, 74% (n = 4,102) reported natural menopause. During a median follow-up of 5.0 years (range 3.1-6.7), 2,157 incident HF events occurred. Compared with women with later onset of menopause, those with early menopause had increased HF risk (HR: 1.27, 95% CI: 1.10–1.47). Risk of HF associated with early menopause was similar in white and black women (p-value for interaction: 0.13). DISCUSSION/SIGNIFICANCE OF IMPACT: In this largely low-income population, early menopause was associated with an increased risk of developing HF. Women with early menopause represent a potential target population for future interventions to decrease risk of HF and cardiovascular risk factors.
Morning coffee is a common remedy following disrupted sleep, yet each factor can independently impair glucose tolerance and insulin sensitivity in healthy adults. Remarkably, the combined effects of sleep fragmentation and coffee on glucose control upon waking per se have never been investigated. In a randomised crossover design, twenty-nine adults (mean age: 21 (sd 1) years, BMI: 24·4 (sd 3·3) kg/m2) underwent three oral glucose tolerance tests (OGTT). One following a habitual night of sleep (Control; in bed, lights-off trying to sleep approximately 23.00–07.00 hours), the others following a night of sleep fragmentation (as Control but waking hourly for 5 min), with and without morning coffee approximately 1 h after waking (approximately 300 mg caffeine as black coffee 30 min prior to OGTT). Individualised peak plasma glucose and insulin concentrations were unaffected by sleep quality but were higher following coffee consumption (mean (normalised CI) for Control, Fragmented and Fragmented + Coffee, respectively; glucose: 8·20 (normalised CI 7·93, 8·47) mmol/l v. 8·23 (normalised CI 7·96, 8·50) mmol/l v. 8·96 (normalised CI 8·70, 9·22) mmol/l; insulin: 265 (normalised CI 247, 283) pmol/l; and 235 (normalised CI 218, 253) pmol/l; and 310 (normalised CI 284, 337) pmol/l). Likewise, incremental AUC for plasma glucose was higher in the Fragmented + Coffee trial compared with Fragmented. Whilst sleep fragmentation did not alter glycaemic or insulinaemic responses to morning glucose ingestion, if a strong caffeinated coffee is consumed, then a reduction in glucose tolerance can be expected.
A major concern of sweetpotato producers is the potential negative effects from herbicide drift or sprayer contamination events when dicamba is applied to nearby dicamba-resistant crops. A field study was initiated in 2014 and repeated in 2015 to assess the effects of reduced rates of N,N-Bis-(3-aminopropyl)methylamine (BAPMA) or diglycloamine (DGA) salt of dicamba, glyphosate, or a combination of these individually in separate trials with glyphosate on sweetpotato. Reduced rates of 1/10, 1/100, 1/250, 1/500, 1/750, and 1/1,000 of the 1× use rate of each dicamba formulation at 0.56 kg ha−1, glyphosate at 1.12 kg ha−1, and a combination of the two at aforementioned rates were applied to ‘Beauregard’ sweetpotato at storage root formation (10 d after transplanting) in one trial and storage root development (30 d after transplanting) in a separate trial. Injury with each salt of dicamba (BAPMA or DGA) applied alone or with glyphosate was generally equal to or greater than glyphosate applied alone at equivalent rates, indicating that injury is most attributable to the dicamba in the combination. There was a quadratic increase in crop injury and a quadratic decrease in crop yield (with respect to most yield grades) observed with an increased herbicide rate of dicamba applied alone or in combination with glyphosate applied at storage root development. However, with a few exceptions, neither this relationship nor the significance of herbicide rate was observed on crop injury or sweetpotato yield when herbicide application occurred at the storage root formation stage. In general, crop injury and yield reduction were greatest at the highest rate (1/10×) of either salt of dicamba applied alone or in combination with glyphosate, although injury observed at lower rates would be cause for concern after initial observation by sweetpotato producers. However, in some cases yield reduction of No.1 and marketable grades was observed following 1/250×, 1/100×, or 1/10× application rates of dicamba alone or with glyphosate when applied at storage root development.
Mild cognitive impairment (MCI) may gradually worsen to dementia, but often remains stable for extended periods of time. Little is known about the predictors of decline to help explain this variation. We aimed to explore whether this heterogeneous course of MCI may be predicted by the presence of Lewy body (LB) symptoms in a prospectively-recruited longitudinal cohort of MCI with Lewy bodies (MCI-LB) and Alzheimer's disease (MCI-AD).
A prospective cohort (n = 76) aged ⩾60 years underwent detailed assessment after recent MCI diagnosis, and were followed up annually with repeated neuropsychological testing and clinical review of cognitive status and LB symptoms. Latent class mixture modelling identified data-driven sub-groups with distinct trajectories of global cognitive function.
Three distinct trajectories were identified in the full cohort: slow/stable progression (46%), intermediate progressive decline (41%) and a small group with a much faster decline (13%). The presence of LB symptomology, and visual hallucinations in particular, predicted decline v. a stable cognitive trajectory. With time zeroed on study end (death, dementia or withdrawal) where available (n = 39), the same subgroups were identified. Adjustment for baseline functioning obscured the presence of any latent classes, suggesting that baseline function is an important parameter in prospective decline.
These results highlight some potential signals for impending decline in MCI; poorer baseline function and the presence of probable LB symptoms – particularly visual hallucinations. Identifying people with a rapid decline is important but our findings are preliminary given the modest cohort size.
Innovation Concept: EM Sim Cases is an innovative, open-access website that was created in 2015 to publish medical simulation resources including standardized, peer-reviewed simulation cases. Herein we describe our interim analysis. Methods: We performed a massive online needs assessment using a methodology previously described by Chan et. al. to determine how we can shape EM Sim Cases to meet the needs of learners and educators who use it. We engaged with simulation experts from the Emergency Medicine Simulation Education Research Collaborative to design a Google Forms survey using best practices in survey design. We distributed the survey to our target community of practice via Twitter, email, and a blog post published on emsimcases.com. Curriculum, Tool, or Material: We received 81 responses from simulation educators representing 8 medical specialties and 13 countries. Most survey respondents identified themselves as staff physicians (n = 44) and specialized in emergency medicine (n = 39). They had 0-21+ years of experience. 37% of respondents (n = 30) stated that material from EM Sim Cases makes up 25% or more of their simulation curriculum. Several respondents noted that using this content made them feel more confident and more current. Respondents praised EM Sim Cases for a well-organized case format, the proper level of detail, consistency between case designs, and the wide variety of cases. Suggested improvements included an opportunity to directly comment on cases and more cases in pediatric, rural, and advanced airway management situations. Suggestions were made to improve the navigability of the website. Respondents wanted to see additional blog content on debriefing strategies and self-made task/skill trainers. Conclusion: EM Sim Cases is a novel, free open-access simulation resource. Using a massive online needs assessment we were able to determine future directions including case topics, website reorganization, and educational material. We were also able to capture how impactful a resource like this can be to clinical and educational practice outside of the simulation setting.
Introduction: In 2018, Canadian postgraduate specialist Emergency Medicine (EM) programs began implementing a competency-based medical education (CBME) assessment system. To support improvement of this assessment program, we sought to evaluate its short-term educational outcomes nationally and within individual programs. Methods: Program-level data from the 2018 resident cohort were amalgamated and analyzed. The number of Entrustable Professional Activity (EPA) assessments (overall and for each EPA) and the timing of resident promotion through program stages was compared between programs and to the guidelines provided by the national EM specialty committee. Total EPA observations from each program were correlated with the number of EM and pediatric EM rotations. Results: Data from 15 of 17 (88.2%) EM programs containing 9,842 EPA observations from 68 of the 77 (88.3%) Canadian EM specialist residents in the 2018 cohort were analyzed. The average number of EPAs observed per resident in each program varied from 92.5 to 229.6 and correlated strongly with the number of blocks spent on EM and pediatric EM (r = 0.83, p < 0.001). Relative to the guidelines outlined by the specialty committee, residents were promoted later than expected and with fewer EPA observations than suggested. Conclusion: We present a new approach to the amalgamation of national and program-level assessment data. There was demonstrable variation in both EPA-based assessment numbers and promotion timelines between programs and with national guidelines. This evaluation data will inform the revision of local programs and national guidelines and serve as a starting point for further reaching outcome evaluation. This process could be replicated by other national assessment programs.
Innovation Concept: A major barrier to the development of a national simulation case repository and multi-site simulation research is the lack of a standardized national case template. This issue was recently identified as a priority research topic for Canadian simulation based education (SBE) research in emergency medicine (EM). We partnered with the EM Simulation Education Researchers Collaborative (EM-SERC) to develop a national simulation template. Methods: The EM Sim Cases template was chosen as a starting point for the consensus process. We generated feedback on the template using a three-phase modified nominal group technique. Members of the EM-SERC mailing list were consulted, which included 20 EM simulation educators from every Canadian medical school except Northern Ontario School of Medicine and Memorial University. When comments conflicted, the sentiment with more comments in favour was incorporated. Curriculum, Tool or Material: In phase one we sought free-text feedback on the EM Sim Cases template via email. We received 65 comments from 11 respondents. An inductive thematic analysis identified four major themes (formatting, objectives, debriefing, and assessment tools). In phase two we sought free-text feedback on the revised template via email. A second thematic analysis on 40 comments from 12 respondents identified three broad themes (formatting, objectives, and debriefing). In phase three we sought feedback on the penultimate template via focus groups with simulation educators and technologists at multiple Canadian universities. This phase generated 98 specific comments which were grouped according to the section of the template being discussed and used to develop the final template (posted on emsimcases.com). Conclusion: We describe a national consensus-building process which resulted in a simulation case template endorsed by simulation educators from across Canada. This template has the potential to: 1. Reduce the replication of effort across sites by facilitating the sharing of simulation cases. 2. Enable national collaboration on the development of both simulation cases and curricula. 3. Facilitate multi centre simulation-based research by removing confounders related to the local adoption of an unfamiliar case template. This could improve the rigour and validity of these studies by reducing inter-site variability. 4. Increase the validity of any simulation scenarios developed for use in national high-stakes assessment.
To explore the efficacy of risperidone long-acting injectable (RLAI) in patients previously treated with oral olanzapine requiring therapy change.
This 6-month, multicenter, prospective, open-label trial evaluated adult patients with psychotic disorders treated with a stable dose of olanzapine, who required a treatment change due to lack of efficacy and/or tolerability. Three weeks after RLAI initiation, olanzapine use was tapered over 1 or 3 weeks at the discretion of the investigator. Primary efficacy evaluation was Positive and Negative Syndrome Scale (PANSS) total score change. Secondary endpoints included PANSS subscales, Clinical Global Impression-Severity (CGI-S), and Global Assessment of Functioning (GAF). Safety was evaluated by recording treatment-emergent adverse events (TEAEs).
96 patients were enrolled (53 tapered olanzapine within 1-week and 43 over 3-weeks). Mean olanzapine baseline dose was 19.2±11.8 and 29.9±17.5 mg/day in 1-week tapering and 3-week tapering groups, respectively. 40.6% of patients were initiated on 25 mg RLAI every-two-weeks. Treatment was completed by 79 patients (82.3%). Treatment discontinuation was mainly due to withdrawal of consent (n=4), AE (n=3), injection refusal (n=2), or lost to follow-up (n=2). Improvements in PANSS total and subscale scores, CGI-S and GAF were significant from baseline to endpoint (p< 0.0001). 74 TEAEs were reported in 42 patients (42.9%). TEAEs reported in ≥2% of patients were agitation (3.6%), insomnia (3.6%), and schizophrenia (9.1%). Serious AEs occurred in 10 patients.
Switching treatment from oral olanzapine to RLAI led to clinically-relevant symptomatic and functional improvement in more than half of all patients. RLAI treatment was generally well-tolerated.