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Ursula Schmidt-Ott,1 Scott Fitzpatrick,2 Zoran Hasanbasic,3 Sergio Leal,3 Peter Morgan-Warren,4 Xin Zhang,3 Kristian T Johnson5 1Bayer AG, Berlin, Germany; 2Bayer AG, Mississauga, Canada; 3Bayer Consumer Care AG, Basel, Switzerland; 4Bayer PLC, Reading, UK; 5Bayer US LLC, Cambridge, MA, USACorrespondence: Ursula Schmidt-Ott, Bayer AG, Müllerstraße 178, Berlin, 13353, Germany, Tel +49 30 468 1111, Email ursula.schmidt-ott@bayer.comPurpose: To determine the reported rates of intraocular inflammation (IOI) in patients treated with intravitreal aflibercept (IVT-AFL) 2 mg in routine clinical practice (ie, outside interventional studies), across all indications and within all countries (excluding the United States), with access to either the vial presentation or pre-filled syringe (PFS).Patients and methods: A search was conducted using the Bayer EYLEA® Global Safety Pharmacovigilance Database for reported cases of IOI and IVT-AFL use between October 2012 and March 31, 2022.Results: With more than 10 years of post-marketing experience with the IVT-AFL vial presentation (> 25 million sold units), and over 2 years of experience with the PFS of IVT-AFL (> 6.7 million sold units) the rate of any IOI, including endophthalmitis, outside the United States was 0.3 events per 10,000 units for the PFS and 1.2 events per 10,000 units for the vial presentation. The event rates specifically for endophthalmitis were 0.1 per 10,000 units for the IVT-AFL PFS and 0.6 per 10,000 units for the IVT-AFL vial presentation.Conclusion: In patients with retinal diseases treated in routine clinical practice with IVT-AFL either from a vial or the PFS, medically important adverse events of IOI, and in particular, endophthalmitis, are infrequently reported events. Numerically, reported rates of IOI and endophthalmitis are low for the vial presentation and even lower for the PFS.Keywords: anti-VEGF, eye, injection, IOI, drug-related side effects and adverse reactions

BACKGROUND: Self-report measures are important in substance use assessment, yet they are susceptible to reporting errors. Urine drug screens (UDS) are often considered a more valid alternative. However, collecting in-person UDS may not always be feasible, contributing to the need to understand factors that influence the validity of self-reported substance use. METHODS: In this secondary analysis of data from 295 women with co-occurring PTSD and substance use disorders (SUD) who participated in a clinical trial testing behavioral interventions, we examined concordance and discordance between self-reported drug use and associated UDS results. Generalized linear mixed models were used to examine the impact of treatment type and participant characteristics on the associations between self-reported drug use and UDS results. RESULTS: Findings revealed higher disagreement between self-report and UDS for opioids and sedatives (ranging from.77 to.90) and lower disagreement rates for cannabis and cocaine (ranging from.26 to.33). Treatment type was not a significant moderator of the associations between self-report and UDS across all drugs. Among those with a positive opioid UDS, those who reported employment in the past three years were more likely to self-report no opioid use compared to their counterparts without employment in the past three years. CONCLUSIONS: Findings add to the literature that supports the validity of self-reported cannabis and cocaine use. The greater discrepancies between self-report and UDS test results of opioids and sedatives suggest adjunctive UDS may be required, although a variety of factors other than inaccurate self-report may be associated with this discrepancy.

Decades of research conducted in Western, Educated, Industrialized, Rich, & Democratic (WEIRD) societies have led many scholars to conclude that the use of mental states in moral judgment is a human cognitive universal, perhaps an adaptive strategy for selecting optimal social partners from a large pool of candidates. However, recent work from a more diverse array of societies suggests there may be important variation in how much people rely on mental states, with people in some societies judging accidental harms just as harshly as intentional ones. To explain this variation, we develop and test a novel cultural evolutionary theory proposing that the intensity of kin-based institutions will favor less attention to mental states when judging moral violations. First, to better illuminate the historical distribution of the use of intentions in moral judgment, we code and analyze anthropological observations from the Human Area Relations Files. This analysis shows that notions of strict liability—wherein the role for mental states is reduced—were common across diverse societies around the globe. Then, by expanding an existing vignette-based experimental dataset containing observations from 321 people in a diverse sample of 10 societies, we show that the intensity of a society's kin-based institutions can explain a substantial portion of the population-level variation in people's reliance on intentions in three different kinds of moral judgments. Together, these lines of evidence suggest that people's use of mental states has coevolved culturally to fit their local kin-based institutions. We suggest that although reliance on mental states has likely been a feature of moral judgment in human communities over historical and evolutionary time, the relational fluidity and weak kin ties of today's WEIRD societies position these populations' psychology at the extreme end of the global and historical spectrum.

Warty dyskeratoma (WD), also called isolated follicular keratosis, is a benign self-limiting lesion regarded as either a follicular part of actinic keratosis or a follicular neoplasm. The etiology of WD remains largely unknown. It typically appears as an isolated small papulonodular lesion in the head and neck area. Intraorally, it usually appears as a white papule with central depression on keratinized mucosa, predominantly on alveolar ridges of both arches and hard palate. Clinically WD may resemble entities such as squamous papilloma, squamous cell carcinoma, or verrucous carcinoma, hence a biopsy is usually required as the standard of care. A 69-year-old man presented with a tiny white, papillary soft tissue lesion on the right lateral border of the tongue. The clinical impression was papilloma. The lesion was completely excised, and microscopic examination revealed a cup-shaped, keratin filled, characteristic acantholytic dyskeratosis with suprabasilar clefting and subjacent connective tissue with adherent basal cells. A diagnosis of WD was rendered. No recurrence has been reported. We present a case of isolated Darier's disease/warty dyskeratoma in an unusual location such as the tongue. Given the rarity of occurrence in this location, WD may not be initially considered by unsuspecting clinicians. Therefore, it is crucial for oral health care providers to be sentient of this entity and consider WD in the differential diagnosis when encountering punctate, papillary, keratotic, or umbilicated lesions of the tongue. [ABSTRACT FROM AUTHOR]