"Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Platysma Prominence: A Randomized Phase 2 Dose-Ranging Study".

BACKGROUND: With aging, repetitive contraction of the platysma leads to an increase in platysma prominence (PP) characterized by the accentuation of vertical neck bands and blunting of the jawline's contour. METHODS: This multicenter, double-blind, phase 2 study evaluated onabotulinumtoxinA (onabotA) treatment in adults with Moderate to Severe PP. Participants were randomized to receive 1 treatment of onabotA low dose (LD), onabotA high dose (HD), or placebo, and were followed for 4 months. Efficacy endpoints were the achievement of a ≥ 1-grade improvement on both the left and right sides at Day 14 at maximum contraction as assessed by the investigator (primary) or by participants (secondary) using validated scales. Safety was evaluated throughout. RESULTS: Participants in the modified intent-to-treat population (N = 164) had a mean age of 50 years; 95.1% were female and 93.9% were White. The primary endpoint was met for both onabotA groups, with investigator-assessed ≥ 1-grade improvement in 77.8% (LD) and 88.2% (HD) vs 12.0% (placebo) of participants on Day 14 (P < 0.0001 vs placebo). Based on participant self-assessment, 75.9% (LD) and 88.2% (HD) vs 18.0% (placebo) achieved ≥ 1-grade improvement on Day 14 (P < 0.0001 vs placebo). Most treatment-related adverse events (AEs) were procedure-related, transient, and mild in severity. The most frequent onabotA-related AE was neck muscle weakness, reported in the HD group. CONCLUSIONS: OnabotA was effective in improving the appearance of PP based on both investigators' and participants' ratings. Treatment was well tolerated.

Health Screening Among a Rural, Hourly Workforce: North Carolina SERVIRE Project.

INTRODUCTION: This study demonstrates the feasibility of a novel, business-partnered, and worksite-based approach to healthcare access to facilitate chronic disease screening and diagnosis among rural hourly workers. The prevalence of undiagnosed and untreated diabetes and hypertension among screening participants was determined. METHODS: From February 2021 to June 2023, investigators partnered with 29 businesses to screen 1,114 workers. Health screenings included a demographic questionnaire, A1c testing for prediabetes (A1c of 5.7-6.4) and diabetes (A1c≥6.5), hypertension (Stage 1: systolic blood pressure of 130-139 mmHg; Stage 2: systolic blood pressure ≥140 mmHg), kidney disease (estimated glomerular filtration rate <60; urine protein ≥1+), and questionnaire assessment of stroke (CHA2DS2-VASc) and sleep apnea (STOP-bang) risk. RESULTS: Of the 1,114 individuals screened (n=632, 56.7% male; n=497, 44.6% Black)), 388 (36%) screened positive for prediabetes or diabetes. Diabetes was previously undiagnosed in 273 (70.4%) of these participants. More than half of the participants (n=680, 62.4%) had an elevated blood pressure reading during the screening, and the majority of these participants (n=445, 65.4%) had not been previously diagnosed with hypertension. In addition, 241 (21.6%) participants were at an increased risk of stroke (CHA2DS2-VASc≥2), and 182 (23.7%) had a STOP-Bang score ≥4, indicating an increased risk of obstructive sleep apnea. CONCLUSIONS: By partnering with local businesses to deliver worksite-based health screenings, high rates of undiagnosed and uncontrolled diabetes and hypertension were identified among the rural, hourly workforce. This worksite-based approach to healthcare access could facilitate early detection of chronic disease, improve patient engagement in the healthcare system, and ultimately yield better long-term public health outcomes.

Treatment of crow's feet lines and forehead lines with Botox (onabotulinumtoxinA): Development, insights, and impact.

Extrinsic and age-related intrinsic factors contribute to the development of facial lines, including lateral canthal lines (called crow's feet lines [CFL]) and horizontal forehead lines (FHL). OnabotulinumtoxinA is a highly effective treatment for facial lines that inhibits acetylcholine release at the neuromuscular junction. This temporary chemical denervation leads to localized muscle relaxation and subsequent wrinkle reduction. Early studies of onabotulinumtoxinA treatment for facial neuronal disorders such as dystonia documented improvements in FHL and CFL. After the neurotoxin was approved for treating frown lines (glabellar lines [GL]), individuals requested treatment for other rhytids, and physicians continued assessing use in new areas. Once onabotulinumtoxinA was in clinical trial development, its efficacy and safety for CFL and FHL were successively evaluated as required by the US Food and Drug Administration and by key global health authorities, including those in the European Union, Japan, and China. Allergan, collaborating with leading physicians, established clinical programs that included novel safety and efficacy measures to meet regulatory requirements. Global, phase 3, randomized, controlled studies of CFL and FHL met rigorous primary endpoints. Some countries mandated clinical trial data beyond US and European regulations, and Allergan conducted 11 studies in total, fulfilling diverse regulatory and study population data requirements. Adverse events associated with local spread, including brow and eyelid ptosis, diplopia, headache, and eyelid sensory disorder, were infrequent and well tolerated. Consequently, onabotulinumtoxinA treatment of upper facial lines is now established globally as a highly effective, minimally invasive treatment for patients to achieve a natural appearance and look younger.

Willingness to Vaccinate Against COVID-19: Predictors of Vaccine Uptake Among Adults in the US.

The uptake of the COVID-19 vaccine will determine the trajectory for improved population health and economic recovery from the COVID-19 pandemic. Identifying factors associated with vaccine acceptance is imperative as public health officials strategize to improve uptake. In this study, we identified predictors of vaccine willingness and acceptance using univariate logistic regression to model predictors and calculate odds ratios. Participants (N = 946) who reported greater vaccine willingness were male, older, and had a higher level of education and income. Behaviors indicative of reducing the spread of COVID-19 (e.g., testing) and perceived risk of COVID-19 infection were associated with vaccine willingness, as were participants who believed they were "highly likely" to be infected (by a factor of 8). Education tailored to demographic groups with low vaccine uptake should focus on the high degree of communicability associated with COVID-19. Implementing mobile healthcare screenings could remove barriers to healthcare, thereby improving health equity.

Discontinuation of Transmission Precautions for COVID-19 Patients: Polymerase Chain Reaction Diagnostics, Patient Delays, and Cycle Threshold Values.

BACKGROUND: The decision of when it is safe to discontinue transmission-based precautions for SARS-CoV-2 coronavirus disease 2019 (COVID-19) hospitalized patients has been controversial. The Centers for Disease Control and Prevention offered reverse transcriptase polymerase chain reaction (PCR) diagnostic test- or symptom-based guidelines. METHODS: A retrospective chart review of Vidant Health system, Eastern North Carolina, was conducted. Length of stay, days in isolation unit, and date appropriate for discharge or isolation discontinuation based on the symptom-based strategy were recorded. RESULTS: Of 196 COVID hospitalized patients, 34 had repeated COVID PCR tests 3 or more days from their first positive test result. Half of these patients experienced delays in release from transmission-based precautions because of repeated positive PCR test results and use of the test-based approach. This resulted in an additional 166 days of hospitalization, costing an estimated $415,000. Furthermore, 2 subjects had a combined 16-day delay in necessary medical procedures. Most of the COVID PCR platforms yield quantitative results in the form of cycle threshold (Ct) values, the number of cycles needed to detect the genome. These values have also been used to assess whether patients are likely to remain contagious. None of our patients who met the criteria for symptom-based strategy for transmission-based precaution discontinuation had positive PCR test results with Ct values lower than 25, but 4 had Ct values lower than 30. CONCLUSIONS: Concerns surround immunocompromised patients and those treated with steroids who might be delayed or incapable of stopping viral replication and thus remain contagious. Our results suggest that clinicians use all available data including Ct values to evaluate the safety of discontinuation of transmission precautions.

Out of Hospital Sudden Death in a Rural Population: Low Rates of ICD Underutilization Among Decedents.

BACKGROUND: Implantable cardioverter defibrillators (ICDs) reduce mortality in patients at risk for life-threatening arrhythmias. Implantation of ICDs in rural or economically disadvantaged populations is suspected to be low. This study examined Out of Hospital Premature Natural Death (OHPND) and electronic medical record (EMR) data to identify rates of non-implantation of ICDs among decedents in eastern North Carolina. METHODS: OHPND cases in 2016 were identified using mortality data and matched with EMRs. Those meeting criteria for ICD implantation based on chart review were adjudicated by two electrophysiologists to determine whether they qualified for implantation. Comorbidity burden was established using Charlson's Comorbidity Index (CCI). RESULTS: Out of 1316 OHPND cases, 967 (73.4%) had EMR records. Chart review identified 70 (7.2%) potential ICD candidates with a LVEF ≤35 of which 5 (7.1%) did not meet criteria because LVEF subsequently improved. Of the remaining 65 patients, 32 (49.2%) already received an ICD, and 33 patients (50.7%) met criteria but had not received one. Reasons for non-implantation included: limited life expectancy secondary to comorbidities, principally chronic kidney disease (CKD) (N = 11, 17%), physician non-adherence to guidelines (N = 9, 14%), loss to follow-up (N = 7, 11%), patient refusal (N = 5, 8%), and death before commencing medical therapy (N = 1, 2%). Among our cohort of 967 individuals who died unexpectedly, nine (0.9%) patients may have avoided death with an ICD. CONCLUSION: This study using decedent data shows low rates of ICD-underutilization in a rural population and emphasizes the role of advanced comorbidities such as CKD in ICD-underutilization.

Safety, Efficacy, and Patient Satisfaction With OnabotulinumtoxinA for the Treatment of Upper Facial Lines in Japanese Subjects.

BACKGROUND: OnabotulinumtoxinA treatment for glabellar lines (GL) or crow's-feet lines (CFL) was previously studied in Japanese subjects. OBJECTIVE: To assess safety and efficacy of repeated onabotulinumtoxinA for moderate to severe GL and CFL in Japanese subjects. METHODS: This 13-month, double-blind, Phase 3 study randomized subjects to onabotulinumtoxinA 44 U (n = 48) or 32 U (n = 53) for CFL and GL for up to 5 treatments (CFL: 24 U or 12 U; GL: 20 U). Outcomes included proportion of subjects achieving none/mild severity at maximum smile (CFL) and maximum frown (GL), using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A); proportion of ≥1-grade improvement responders at maximum smile and at rest (CFL), at maximum frown and at rest (GL); subject-reported outcomes; and safety. RESULTS: Most subjects were responders (none/mild on FWS-A; CFL: 89.6% [44 U], 84.9% [32 U]; GL: 93.8% [44 U], 98.1% [32 U]) on Day 30. Across treatment groups, responder rates were consistent over time and treatments. Most subjects were satisfied with improved CFL appearance and with treatment. Incidence of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs across groups was similar. All TEAEs but one (peritonitis) were mild or moderate. CONCLUSION: Repeated onabotulinumtoxinA was effective and well tolerated.

Safety and Efficacy of OnabotulinumtoxinA for Treatment of Crow's Feet Lines in Chinese Subjects.

BACKGROUND: This study evaluated the safety and efficacy of onabotulinumtoxinA for the treatment of crow's feet lines (CFL) in Chinese subjects. METHODS: This 5-month, double-blind, randomized, parallel-group, placebo-controlled phase 3 study was conducted in China. Subjects with moderate-to-severe CFL at maximum smile received a single treatment of onabotulinumtoxinA 24 U (total; n = 316) or placebo (n = 101) on day 1. The primary efficacy measure was the proportion of investigator-assessed responders (achieved CFL severity of none or mild at maximum smile using the Facial Wrinkle Scale with Asian Photonumeric Guide at day 30). Additional endpoints included other response definitions (achieving at least 1-grade improvement at maximum smile and at rest using the Facial Wrinkle Scale with Asian Photonumeric Guide at day 30), duration of effect, subject-reported outcomes, and safety. RESULTS: All efficacy endpoints were met. At day 30, the proportion of subjects achieving none or mild severity at maximum smile was significantly greater (P < 0.001) in the onabotulinumtoxinA group (63.9%) versus the placebo group (5.0%). The proportion of subjects assessing the change in CFL appearance as much improved/very much improved was also significantly greater with onabotulinumtoxinA than placebo (P < 0.001). Subjects' self-assessed outcomes were similar to investigator-assessed results. Median duration of effect with onabotulinumtoxinA was ≥5 months using all responder definitions. A low occurrence of treatment-related adverse events was reported, with no new safety findings. CONCLUSIONS: OnabotulinumtoxinA 24 U was effective and well tolerated for the treatment of CFL in Chinese subjects, with responses maintained over 5 months.

Phase 3 Study of OnabotulinumtoxinA Distributed Between Frontalis, Glabellar Complex, and Lateral Canthal Areas for Treatment of Upper Facial Lines.

BACKGROUND: Although commonly practiced, simultaneous onabotulinumtoxinA injections to multiple facial areas have not been investigated in prospective studies. OBJECTIVE: Evaluate safety and efficacy of onabotulinumtoxinA for treatment of forehead lines (FHL) distributed between the frontalis (20 U) and glabellar complex (20 U), with or without simultaneous lateral canthal areas (crow's feet lines [CFL], 24 U) treatment. METHODS: Subjects with moderate to severe FHL were randomized (2:2:1) to onabotulinumtoxinA 40 U, onabotulinumtoxinA 64 U, or placebo. After 180 days, subjects could receive up to 2 additional open-label onabotulinumtoxinA 64 U treatments. RESULTS: The intent-to-treat (ITT) population comprised 787 subjects, and the modified ITT (mITT) population (subjects with psychological impact) comprised 568. After 30 days, onabotulinumtoxinA 40 U and 64 U significantly improved investigator- and subject-assessed FHL severity by at least 2 Facial Wrinkle Scale (FWS) grades in 45.6% and 53.0% of ITT subjects, respectively, versus 0.6% receiving placebo (both, p < .0001). Significantly more mITT subjects receiving onabotulinumtoxinA achieved investigator- and subject-assessed FWS ratings of none/mild versus placebo (p < .0001). OnabotulinumtoxinA was well tolerated. CONCLUSION: OnabotulinumtoxinA distributed between the frontalis and glabellar complex, with or without additional CFL injections, was safe and effective for treatment of moderate to severe FHL.

Underweight Status Is an Independent Predictor of In-Hospital Mortality in Pediatric Patients on Extracorporeal Membrane Oxygenation.

BACKGROUND: Malnutrition is associated with an increased risk of mortality in patients admitted to the intensive care unit. Children requiring extracorporeal membrane oxygenation (ECMO) support represent an extremely ill subset of this population. There is a lack of data on the impact of nutrition state on survival in this cohort. We examined the association between being underweight and in-hospital mortality among children supported with ECMO. MATERIALS AND METHODS: This article reports on an observational retrospective cohort study performed among neonatal and pediatric patients supported with ECMO in a tertiary children's hospital from May 1996 through June 2013. Nutrition status on intensive care unit admission was defined with z scores on weight for length and body mass index. RESULTS: Patients (N = 491) had a median age of 31 days (interquartile range, 2-771): 24.4% were underweight, and 8.9% were obese. During ECMO support, 88.3% received total parenteral nutrition, and 30.3% received enteral nutrition. Median maximum energy intake while receiving ECMO was 82 kcal/kg/d (interquartile range, 54.7-105). Multiple logistic regression showed that underweight status was associated with increased predicted odds of in-hospital mortality when compared with normal weight (odds ratio: 1.99, 95% confidence interval: 1.21-3.25, P = .006). Other factors associated with increased odds of mortality included extracorporeal cardiopulmonary resuscitation and the need for continuous renal replacement therapy. CONCLUSION: Underweight status was an independent predictor for in-hospital mortality in our cohort of pediatric ECMO patients. Prospective studies evaluating the impact of metabolic state of children on ECMO should further define this relationship.

OnabotulinumtoxinA (Botox) in the Treatment of Crow's Feet Lines in Japanese Subjects.

BACKGROUND: This study evaluated the safety and efficacy of onabotulinumtoxinA in Japanese subjects with crow's feet lines (CFL). METHODS: This phase 3, multicenter, double-blind, randomized study included 2 treatment periods: 6-month placebo-controlled period followed by a 7-month open-label period. In period 1, subjects with moderate to severe CFL received onabotulinumtoxinA 24 U (n = 104) or 12 U (n = 99), or placebo (n = 97). In period 2, placebo subjects switched to onabotulinumtoxinA 24 U or 12 U (double-blind dose). Up to 5 total treatments were permitted for subjects meeting re-treatment criteria. The primary efficacy measure was the proportion of investigator-assessed responders (achieving CFL severity of none or mild at maximum smile using the Facial Wrinkle Scale with Asian Photonumeric Guide [FWS-A] at day 30 of treatment 1). Additional endpoints included other responders (achieving at least 1-grade improvement at maximum smile and at rest using the FWS-A at day 30), responders at other time points, duration of effect, subject-reported outcomes, and safety. RESULTS: All efficacy endpoints were met. At day 30, the proportion of subjects achieving none or mild severity at maximum smile was significantly greater (P < 0.001) in the onabotulinumtoxinA 24 and 12 U groups (68.3 and 56.6%, respectively) compared with the placebo group (8.2%). Efficacy results were consistent over repeated treatments, and subjects' self-assessed outcomes were similar to investigator-assessed results. CONCLUSIONS: Treatment with onabotulinumtoxinA 24 and 12 U improved the appearance of CFL in Japanese subjects and was well tolerated, with no new safety findings. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Forehead Line Treatment With OnabotulinumtoxinA in Subjects With Forehead and Glabellar Facial Rhytids: A Phase 3 Study.

BACKGROUND: Effacement of horizontal forehead lines (FHL) with onabotulinumtoxinA has not been investigated in prospective Phase 3 studies. OBJECTIVE: To evaluate safety and efficacy of onabotulinumtoxinA treatment of FHL together with glabellar lines (GL). MATERIALS AND METHODS: A 12-month, Phase 3 study randomized subjects with moderate-to-severe FHL and GL to onabotulinumtoxinA 40 U or placebo, distributed between the frontalis (20 U) and glabellar complex (20 U). After Day 180, subjects could receive up to 2 additional open-label onabotulinumtoxinA treatments. Efficacy was assessed using the Facial Wrinkle Scale (FWS) and Facial Line Outcomes questionnaire. RESULTS: The intent-to-treat (ITT) population included 391 subjects, and the modified ITT (mITT) population (subjects with psychological impact) included 254 subjects. After 30 days, onabotulinumtoxinA significantly improved the investigator- and subject-assessed appearance of FHL severity by at least 2 FWS grades in 61.4% of ITT subjects versus 0% of placebo subjects (p < .0001). In the mITT population, 94.8% of onabotulinumtoxinA subjects and 1.7% of placebo subjects achieved investigator- and subject-assessed FWS ratings of none/mild (p = .0003). Patient-reported outcomes were consistent with FWS ratings. OnabotulinumtoxinA was well tolerated. CONCLUSION: OnabotulinumtoxinA 40 U distributed between the frontalis and glabellar complex was safe and effective for treatment of moderate-to-severe FHL.

OnabotulinumtoxinA for Treatment of Moderate to Severe Crow's Feet Lines: A Review.

Lateral canthal lines or crow's feet lines (CFL) may be treated with onabotulinumtoxinA. We identified several key concepts important to understanding the use of onabotulinumtoxinA for treatment of moderate-to-severe CFL. To contextualize and integrate data on the recommended dose and injection patterns of onabotulinumtoxinA for treatment of CFL, we summarized data from pivotal clinical studies in the development of onabotulinumtoxinA for treatment of CFL. Data from key studies of onabotulinumtoxinA for CFL are presented. The efficacy and safety of onabotulinumtoxinA treatment of moderate-to-severe CFL were evaluated in 2 randomized, controlled phase 3 studies comprising 1362 patients. The 24U total dose of onabotulinumtoxinA used in these studies was based on a phase 2 dose-ranging trial. Two injection patterns were available to investigators; each involved 3 injection sites per side in the lateral orbicularis oculi muscle. A cross-sectional analysis of photographs from the phase 3 trials provided detailed information on the frequency of 4 distinct CFL patterns. In the primary efficacy analysis for each phase 3 trial, CFL responder rates were significantly greater with onabotulinumtoxinA vs placebo at day 30 (P< .001). Eyelid edema (1%) was the only adverse event reported in ≥ 1% of patients receiving onabotulinumtoxinA, occurring more frequently with onabotulinumtoxinA than with placebo. The studies showed that onabotulinumtoxinA is effective and generally well-tolerated for CFL treatment. Additionally, 2 different injection patterns allow physicians to tailor treatment based on a patient's CFL pattern.

Efficacy and safety of onabotulinumtoxinA for treating crow's feet lines alone or in combination with glabellar lines: a multicenter, randomized, controlled trial.

BACKGROUND: This was the second study in a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA. OBJECTIVE: To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL alone or with glabellar lines (GL). METHODS: This multicenter, double-blind, placebo-controlled, repeat treatment, 7-month study randomized subjects with moderate-to-severe CFL and GL (maximum contraction) to onabotulinumtoxinA 44 U (CFL: 24 U, GL: 20 U; n = 305), onabotulinumtoxinA 24 U (CFL: 24 U, GL: placebo; n = 306), or placebo (n = 306). Coprimary end points were investigator-assessed and subject-assessed proportion of subjects achieving a CFL Facial Wrinkle Scale Grade of 0 or 1 (maximum smile; Day 30, Cycle 1). Additional efficacy end points and safety/adverse events (AEs) were evaluated. RESULTS: All primary and secondary end points were achieved; statistically significant differences favored onabotulinumtoxinA (p < .001, all comparisons vs placebo). Investigator and subject responder rates were: CFL, 54.9% and 45.8%; CFL + GL, 59.0% and 48.5%; and placebo, 3.3% (both), respectively. Responder rates on other end points also significantly favored onabotulinumtoxinA treatments. Most AEs were mild or moderate. Two subjects discontinued: 1 serious AE unrelated to treatment (myocardial infarction) and 1 treatment-related AE (injection site pain). CONCLUSION: OnabotulinumtoxinA was effective and well tolerated for treating moderate-to-severe CFL alone or in combination with GL.

Effects of OnabotulinumtoxinA treatment for crow's feet lines on patient-reported outcomes.

BACKGROUND: Although millions of aesthetic procedures are performed annually, few patient-reported outcome (PRO) measures have been used in this setting. OBJECTIVE: To evaluate the impact of onabotulinumtoxinA treatment for crow's feet lines (CFL) on relevant psychological variables and self-perception of age/appearance in subgroup populations. MATERIALS AND METHODS: Facial Lines Outcomes (FLO-11) Questionnaire, Self-Perception of Age (SPA), and Subject Global Assessment of Change in CFL (SGA-CFL) were PRO measures administered in 2 Phase 3, double-blind placebo-controlled trials for the treatment of CFL alone or CFL/glabellar lines (GL). Patient-reported outcome measures were analyzed by subgroups (age, gender, and baseline CFL severity). Subject satisfaction with appearance was also analyzed. RESULTS: Most subgroups receiving onabotulinumtoxinA demonstrated significant improvements in psychological impact (FLO-11 Items 2, 5, and 8) versus placebo at Day 30 (p ≤ .05). OnabotulinumtoxinA-treated subjects consistently rated themselves as looking younger on SPA versus placebo in all subgroups at Day 30 (p ≤ .05) and showed significant improvements in CFL appearance versus placebo at all time points on SGA-CFL. Overall, subjects were satisfied with their appearance. CONCLUSION: OnabotulinumtoxinA-treated subjects experienced significant improvements in perceived appearance, attractiveness, tiredness, age, and satisfaction versus placebo. Subjects treated for CFL and GL experienced even greater effects.

Efficacy and safety of onabotulinumtoxinA for the treatment of crows feet lines: a multicenter, randomized, controlled trial.

BACKGROUND: This study was part of a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA. OBJECTIVE: To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL. METHODS: This multicenter, double-blind, placebo-controlled, 5-month study randomized subjects with moderate-to-severe CFL (maximum smile) to onabotulinumtoxinA (24 U; n = 222) or placebo (n = 223). Investigators and subjects assessed CFL severity (maximum smile and rest) using the 4-grade Facial Wrinkle Scale (FWS). Co-primary end points were investigator- and subject-assessed proportion of subjects achieving a CFL FWS grade of 0 (none) or 1 (mild) at maximum smile (Day 30). Additional efficacy end points, patient-reported outcomes, and safety/adverse events (AEs) were evaluated. RESULTS: All primary and secondary end points were achieved; statistically significant differences favored onabotulinumtoxinA (p < .001, all comparisons vs placebo). Co-primary responder rates were 66.7% compared with 6.7% for investigator-assessed and 58.1% compared with 5.4% for subject-assessed response (onabotulinumtoxinA group and placebo, respectively; p < .001). A significantly greater proportion of the onabotulinumtoxinA group than placebo group achieved a 1 grade or greater improvement on the FWS (maximum smile and rest assessed by both the investigator and subject; all time points; p < .001). Most AEs were mild or moderate and did not result in discontinuations. CONCLUSION: Treatment of moderate-to-severe CFL with onabotulinumtoxinA was effective and well tolerated.

Diagnosis and antimicrobial therapy of Mycoplasma hominis meningitis in adults.

Meningitis in adults due to infection with Mycoplasma hominis is rarely reported. Here, we document the third case of M. hominis meningitis in an adult individual, developed upon neurosurgery following a subarachnoid haemorrhage. Our findings are noteworthy, because the presence of M. hominis in cerebrospinal fluid cannot be identified by standard culturing, Gram-staining, or matrix-assisted laser desorption ionization time-of-flight mass spectrometry. Importantly, however, 16S rDNA sequencing did lead to an unambiguous diagnosis and guided successful antimicrobial therapy. Based on our present findings and a review of the respective literature, we conclude that M. hominis should be considered as a candidate causative agent of infections of the central nervous system following neurosurgical procedures, especially if there is no response to standard antimicrobial therapy, and routine culturing yields negative results.