Comparing the effectiveness of two educational methods for oral health management in COVID-19 pandemic among dental professionals.

AIM. The aim of this study was to train dentists on the different oral hygiene measures to be followed by COVID-19 patients via Webinar and Information Education Communication (IEC) Materials and compare the effectiveness of both. METHODOLOGY. A total of 100 dental professionals were included by non-probability convenience sampling. Webinar and IEC Materials on oral hygiene measures, oral symptoms, and management strategies during COVID-19 were created and training was conducted for all dental professionals who registered themselves. An online version of the self-administered questionnaire (English) was created on the official Edantseva website and circulated to all the registered participants to obtain the pre and post-training data. RESULTS. Out of the total 80 participants in the Webinar group, 47 were females and 33 were males. Comparing the mean total scores obtained by the participants in the webinar and IEC groups in the pre and post-test showed that there is a significant difference in the scores obtained by the participants in the two groups in the pre and post-test (p<0.01). CONCLUSION. Educating dentists via IEC Materials was effective in improving their knowledge regarding oral health management during the COVID-19 pandemic. IEC materials being handy and referable at any time was found to be more effective.

External Validation of a Venous Thromboembolic Risk Score for Cancer Outpatients with Solid Tumors: The COMPASS-CAT Venous Thromboembolism Risk Assessment Model.

BACKGROUND: Current risk assessment models (RAMs) for prediction of venous thromboembolism (VTE) risk in the outpatient cancer population have shown poor predictive value in many of the most common cancers. The Comparison of Methods for Thromboembolic Risk Assessment with Clinical Perceptions and AwareneSS in Real Life Patients-Cancer Associated Thrombosis (COMPASS-CAT) RAM was derived in this patient population and predicted patients at high risk for VTE even after initiation of chemotherapy. We sought to externally validate this RAM. MATERIALS AND METHODS: Patients aged ≥18 years who presented to a tertiary care center between January 1, 2014, and December 31, 2016, with invasive breast, ovarian, lung, or colorectal cancers were included. The COMPASS-CAT RAM was applied using our health system's tumor registry and variables that were identified by International Statistical Classification of Diseases and Related Health Problems-9 and -10 codes of the electronic health record and independent chart review. The primary endpoint at 6-month study follow-up was documented VTE. RESULTS: A total of 3,814 patients were included. Documented VTE at 6-month follow-up occurred in 5.85% of patients. Patients stratified into low/intermediate- and high-risk groups had VTE rates of 2.27% and 6.31%, respectively. The sensitivity, specificity, and negative and positive predictive value of the RAM were 95%, 12%, 97.73%, and 6.31%, respectively. Diagnostic accuracy via receiver operating characteristic curve was calculated at 0.62 of the area under the curve. CONCLUSION: In this large retrospective external validation study of the COMPASS-CAT RAM for VTE in patients with cancer undergoing active treatment, model discrimination was moderate and calibration was poor. The model had good negative predictive value. Further prospective validation studies-especially within 6 months of cancer diagnosis-are needed before the model can be implemented into routine clinical practice for primary thromboprophylaxis of high-VTE-risk patients with cancer with solid tumors. IMPLICATIONS FOR PRACTICE: This study provides further guidance for researchers and clinicians in determining clinical and laboratory risk factors associated with development of venous thromboembolism among the ambulatory population of patients being treated for lung, breast, colorectal, or ovarian cancer. It validates the COMPASS-CAT risk model that was developed in this cancer population and suggests that further prospective validation of the model, with more focus on patients within 6 months of their index cancer diagnosis, would likely enhance the accuracy and usefulness of this model as a clinical prediction tool.

Unusual foreign body in the nasal cavity of an adult with repaired cleft lip and palate.

Intranasal foreign bodies arising from dental clinical practice, especially in patients with cleft lip and palate (CLP) occur rarely and are very scarce in the literature. This article reports an unusual case of a dental impression material presenting as a foreign body in the nasal cavity of an adult with repaired CLP who presented for dental prosthetic rehabilitation. To our knowledge, this is only the second report presenting nasal foreign body in a cleft patient arising due to a dental impression procedure.

Clinical profile and demographic distribution of band shaped keratopathy in India: A study of 8801 patients.

Purpose: To describe the clinical profile and demographic distribution of band-shaped keratopathy (BSK) in patients presenting to a multitier ophthalmology hospital network in India. Methods: This cross-sectional hospital-based study included 2,664,906 new patients presenting between January 2011 and January 2021 (10-year period). Patients with a clinical diagnosis of BSK in at least one eye were included as cases. The data were collected using an electronic medical record system. Results: Overall, 8801 (0.33%) patients were diagnosed with BSK. The prevalence rates were 0.47% in children (age: <16 years) and 0.31% in adults. The majority of patients were males (62.87%) with unilateral affliction (85.21%). The mean age of the patients was 40.43 ± 23.14 years. The majority (16.93%) of the patients were in the age bracket of 11-20 years. A larger proportion of the patients were from higher socioeconomic status (60.46%) and the urban region (45.9%). Of the 10,103 eyes affected with BSK, the common ocular comorbidities were status post-vitreoretinal surgery (20.55%) and uveitis (12.7%) in children and corneal scar (41.23%) and spheroidal degeneration (13.7%) in adults. Most of the eyes had mild or no visual impairment (24.74%). Among the eyes that needed surgical intervention, chelation with ethylenediaminetetraacetic acid (EDTA) was the most performed surgical procedure (1.68%) along with phototherapeutic keratectomy (0.32%). Conclusion: BSK commonly affects adult males and is unilateral in nature. The majority of the patients in this cohort belonged to higher socioeconomic strata and urban geography. At initial presentation, visual impairment was mild to moderate in a vast majority of the patients, and the most common surgical intervention performed was chelation with EDTA during the study period.

Pediatric Autoimmune Neuropsychiatric Disorders Associated With Group A Streptococci: Etiopathology and Diagnostic Challenges.

Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) have attracted a lot of interest and discussion since it was originally characterized in 1998. The role of streptococcal infection in children with abrupt-onset obsessive-compulsive disorder (OCD) and new-onset tics, the natural history of this entity, and the role of symptomatic and disease-modifying therapies, such as antibiotics, immunotherapy, and psychoactive drugs, are still unresolved issues. Alternative therapies for acute-onset OCD have been developed based on this postulated pathophysiology, including antibiotics and immunomodulatory therapy. The literature on PANDAS therapy is varied but there is no clinical consensus on the treatment of choice. While there is no convincing evidence for the autoimmune rationale for PANDAS, given the increased attention to this entity and the apparent growth in usage of this diagnostic category, it is critical to address concerns about the condition's diagnosis, treatment, and pathogenesis. We conducted a multi-language literature search on Medline, Cochrane, Embase, and Google Scholar for a period spanning until October 2021. The following search strings and Medical Subject Heading (MeSH) terms were used: "PANDAS," "Group A Streptococcus," "OCD," and "tics." We explored the literature on PANDAS in terms of its epidemiology, pathophysiology, the role of group A streptococcal infection, associated complications, and prophylactic and treatment modalities. We examined current working definitions of PANDAS, analyzed differential diagnoses, and published pieces of evidence for therapies associated with this entity, with a view to proposing a therapeutic strategy for children with acute symptoms that meet PANDAS criteria, in this review article.

Clinical profile and demographic distribution of pellucid marginal corneal degeneration in India: A study of 559 patients.

PURPOSE: The aim of this study was to describe the clinical profile and demographic distribution of pellucid marginal corneal degeneration (PMD) in patients presenting to a multitier ophthalmology hospital network in India. METHODS: This cross-sectional hospital-based study included 2,470,793 new patients presenting between September 2012 and September 2020 (~8 years period). Patients with a clinical diagnosis of PMD in at least one eye were included as cases. The data were collected using an electronic medical record system. RESULTS: Overall, 559 (0.02%) new patients were diagnosed with PMD. The prevalence rates were 0.004% in children (age <16 years) and 0.03% in adults. The majority of patients were males (70.13%) with the bilateral affliction (77.1%). The mean age of the patients was 37.91 ± 13.19 years. The majority (30.23%) of the patients were between 31 and 40 years of age. A significant number of patients were from higher socioeconomic status (93.74%) and from the urban region (45.08%). Of the 990 eyes, the most common clinical signs were ectasia/thinning (58.99%), corneal scar (17.47%), and corneal hydrops (1.01%). The majority of the eyes (87.97%) were managed with either spectacles or contact lenses. Among those who had surgical intervention, collagen cross-linking was the most performed procedure (5.25%) followed by cataract surgery (4.14%). CONCLUSION: PMD is a rare disease affecting patients seeking eye care in India. It commonly affects adult males and is bilateral in nature. The disease progression is slow and usually occurs beyond 3 years. Conservative management is more common than surgical intervention.

Perceived oral health beliefs, traditional practices, and oral health status of nomads of Tamilnadu: A cross-sectional study.

AIM: To assess the perceived oral health beliefs, traditional practices, and oral health status of nomads. METHODS: A cross-sectional study was conducted among 115 nomads residing in various places of Tamilnadu. Information regarding socio-demographics such as age, gender, occupation, and place of residence were obtained. Study participants were interviewed with a pre-tested questionnaire consisting questions related to oral health beliefs and oral health practices. Clinical examination was carried out to record the oral health status using a proforma. RESULTS: A significant Chi-square association was found with oral health-related beliefs (P < 0.01). However, 30.9% had perceived strong beliefs, 64.3% of the subjects used toothbrush, and 20% had at least one oral mucosal lesion. CONCLUSION: A significant proportion of nomads had perceived oral health beliefs, which had a significant association with their traditional practices and their oral health was much deteriorated.

Residual solvent analysis in hydrochloride salts of active pharmaceutical ingredients.

GMP conditions commands to control adequately the quality of APIs by checking the levels of residual solvents. Organic solvents such as acetone, ethyl acetate, isopropyl alcohol, methanol, tetrahydrofuran and toluene frequently used in pharmaceutical industry for the manufacturing of Active Pharmaceutical ingredients (APIs). A selective Gas Chromatographic (GC) method has been developed and validated as per ICH guidelines for residual solvent analysis in 10 different hydro chloride salts of APIs. Residual solvents in APIs were monitored using gas chromatography (GC) with Flame Ionisation detector (FID). The separation was carried out on BP 624 column (30 mx0.53 mm i.d.x0.25 m coating thickness), using GC 17 A shimadzu, with nitrogen as carrier gas in the split mode by direct injection method. The method described is simple, sensitive, rugged, reliable and reproducible for the quantitation of acetone, ethyl acetate, isopropyl alcohol, methanol, tetrahydrofuran and toluene at residual level from hydrochloride chloride salts of APIs.

Illustrated accounts of coccinellid predators of Maconellicoccus hirsutus (Green) (Hemiptera: Sternorrhyncha: Pseudococcidae) on mulberry in India, with description of a new species of Scymnus Kugelann (Coleoptera: Coccinellidae) from West Bengal.

The pink hibiscus mealybug, Maconellicoccus hirsutus (Green), is a major pest of mulberry (Morus alba L.), the sole host of the mulberry silkworm, Bombyx mori (L.), which is a source of livelihood to millions of sericulture farmers in India. Several predators, mainly Coccinellidae (Coleoptera), have been reported to feed on M. hirsutus on mulberry. Coccinellid predators of M. hirsutus collected on mulberry from different parts of India are illustrated here with brief diagnostic notes to facilitate their identification. An account of mycophagous species of coccinellids commonly found on mulberry and misreported as predators of mulberry pests is also given with illustrations. Scymnus (Pullus) latifolius sp. nov., a promising predator of M. hirsutus, hitherto misidentified and reported as Scymnus pallidicollis Mulsant, is described and illustrated from West Bengal, India, with detailed biological notes. Keiscymnus taiwanensis Yang Wu, 1972 is reduced to a new junior synonym of Scymnus pallidicollis Mulsant, 1853 (syn. nov.). Illeis bielawskii Ghorpade, 1976 is found to be a valid species and removed from synonymy with I. bistigmosa Mulsant, 1850 (stat. rev.).

Expression of oncofoetal marker carcinoembryonic antigen in oral cancers in South India--a pilot study.

Expression of the oncofoetal glycoprotein, carcinoembryonic antigen (CEA), has been observed in a number of malignancies and is also being pursued as a target for anti-cancer therapy. This study explored the status of this biochemical entity in the oral squamous cell carcinoma (SCC) in South India caused by extensive chewing habits. Squamous cell carcinoma in the study belonged to grade I and grade II. Tumour staging of the patients recruited in the study ranged from T2N1M0 to T4N3M0. Of the grade II cases studied, 88% (7 out of 8) showed expression of CEA. The 2 cases of grade I SCC of buccal mucosa also showed positive anti-CEA staining. If the results from this pilot study can be validated with a larger sample size, a role can be attributed to this tumour marker in oral neoplasia, thereby opening up avenues for using CEA as an additional diagnostic marker in oral SCC in this population and as a possible target for anti-cancer therapy.

PCR detection and typing of human papilloma virus DNA in squamous carcinoma of the cervix in a cohort of Sri Lankan women.

OBJECTIVE: To determine the prevalence of human papilloma virus (HPV) types 16 and 18 in squamous carcinomas of the cervix in Sri Lanka. DESIGN: Case control study. SETTING: One gynaecological unit at the Cancer Institute, Maharagama, Sri Lanka. PATIENTS: 15 patients with squamous carcinoma of the cervix, and 15 age matched controls with histologically normal cervices. MEASUREMENTS: DNA was extracted from paraffin embedded cervical biopsies. Polymerase chain reaction was performed on extracted DNA employing primers specific for HPV types 16 and 18. RESULTS: HPV 16 DNA was detected in 11 out of 15 cervical cancer biopsies (73.3%), in comparison with 3 out of 15 normal controls (20%). HPV 18 was detected in 3 out of 15 cervical cancer biopsies, but not in a single control biopsy. CONCLUSION: Despite the limited number of cases in this cohort, this study supports the strong association between HPV 16 and squamous cancer of the cervix.

Assessment of the pathogenicity of cell-culture-adapted Newcastle disease virus strain Komarov.

Newcastle disease vaccines hitherto in vogue are produced from embryonated chicken eggs. Egg-adapted mesogenic vaccines possess several drawbacks such as paralysis and mortality in 2-week-old chicks and reduced egg production in the egg-laying flock. Owing to these possible drawbacks, we attempted to reduce the vaccine virulence for safe vaccination by adapting the virus in a chicken embryo fibroblast cell culture (CEFCC) system. Eighteen passages were carried out by CEFCC, and the pathogenicity was assessed on the basis of the mean death time, intracerebral pathogenicity index, and intravenous pathogenicity index, at equal passage intervals. Although the reduction in virulence demonstrated with increasing passage levels in CEFCC was encouraging, 20% of the 2-week-old birds showed paralytic symptoms with the virus vaccine from the 18(th)(final) passage. Thus, a tissue-culture-adapted vaccine would demand a few more passages by CEFCC in order to achieve a complete reduction in virulence for use as a safe and effective vaccine, especially among younger chicks. Moreover, it can be safely administered even to unprimed 8-week-old birds.

Comparing the Structure-Function Relationship at the Macula With Standard Automated Perimetry and Microperimetry.

PURPOSE: To compare the structure-function relationship between ganglion cell-inner plexiform layer (GCIPL) thickness measurements using spectral-domain optical coherence tomography (SDOCT) and visual sensitivities measured using standard automated perimetry (SAP) and microperimetry (MP) at the macula in glaucoma. METHODS: In a prospective study, 45 control eyes (29 subjects) and 60 glaucoma eyes (45 patients) underwent visual sensitivity estimation at the macula (central 10°) by SAP and MP, and GCIPL thickness measurement at the macula by SDOCT. Structure-function relationships between GCILP thickness and visual sensitivity loss with SAP and MP at various macular sectors were assessed using the Hood and Kardon model. To compare structure-function relationship with SAP and MP, we calculated the number of data points falling outside the 5th and the 95th percentile values of the Hood and Kardon model with each of the perimeters. RESULTS: The number of points falling outside the 5th and 95th percentile values of the Hood and Kardon model ranged from 28 (superior sector) to 48 (inferonasal sector) with SAP and 33 (superior sector) to 49 (inferonasal sector) with MP. The difference in the number of points falling outside the 5th and 95th percentile values with SAP and MP was statistically insignificant (P > 0.05, χ(2) test) for all the sectors. CONCLUSIONS: Visual sensitivity measurements of both SAP and MP demonstrated a similar relationship with the GCIPL measurements of SDOCT at the macula in glaucoma.

Structure-Function Relationship in Glaucoma Using Ganglion Cell-Inner Plexiform Layer Thickness Measurements.

PURPOSE: To evaluate the structure-function relationship between ganglion cell-inner plexiform layer (GCIPL) thickness at the macula and 10-2 standard automated perimetry (SAP) in glaucoma and to evaluate the relationship using a recently proposed linear model. METHODS: In a cross-sectional analysis, structure-function relationship was determined in 50 glaucomatous eyes (40 patients, mean deviation: -15.4 ± 7.5 dB) and 21 control eyes (13 subjects, mean deviation: -3.4 ± 3.0 dB), which had undergone 10-2 SAP and GCIPL imaging on the same day. Functional loss was derived from total deviation numerical values on 10-2 SAP and calculated on both a linear (reciprocal of Lambert) and a decibel scale after accounting for the retinal ganglion cell displacement at the macula. Strength of relationship was reported as coefficient of determination (R2) of the linear regression models fitted to the data separately for different sectors. The relationship was also evaluated using a linear model. RESULTS: The R2 for the associations between GCIPL thickness sectors and the corresponding sector SAP total deviation values ranged from 0.19 (for superonasal GCIPL sector) to 0.60 (for average GCIPL thickness) when functional loss was calculated on the decibel scale and 0.16 (for superonasal sector) to 0.54 (for inferior sector) on the linear scale. All associations were statistically significant (P < 0.05). The linear model fitted the data reasonably well. CONCLUSIONS: Significant structure-function associations were found between GCIPL thickness measurements at the macula and the functional loss measured on 10-2 SAP in glaucoma. Best fit was found for the inferior and average GCIPL sector thickness. The linear model was useful to study the structure-function relationship.

Variant complex translocation t(8;15;21) in acute myeloblastic leukemia (M2) associated with bilateral chloroma.

Complex translocation t(8;15;21)(q22;q21;q22) in a 9-year-old female with acute myeloblastic leukemia (M2) with bilateral chloroma is described. This particular variant type of translocation in M2 type is rare. The importance of variant translocation in defining the critical segment on the chromosomes responsible for phenotypic expression of the disease is emphasized.

Association of Burkitt's lymphoma with the Epstein-Barr virus in two developing countries.

The clinical presentation of Burkitt's lymphoma (BL) and it's association with the Epstein-Barr virus (EBV) varies in different geographic areas, BL in developing countries being "intermediate" between the sporadic and endemic types, both in it's clinical presentation and it's association with EBV, which varies from 25-80%. In this study we have analysed the clinical features, EBV association, subtype and prevalence of the deleted variant of the Latent Membrane Protein-1 (LMP-1) of EBV in forty-two cases from two developing countries- India (n = 25) and Argentina (n = 17). In both countries the abdomen was the site most commonly involved while jaw involvement was rare. EBV was detected by in-situ hybridization using the EBER-1 RNA probe. 47% of cases from Argentina and 80% of cases from India were EBER positive. EBV typing using EBNA-3C primers showed a predominance of Type A in both countries (India-13/16 and Argentina-(7/8)). The 30bp deletion of the LMP-1 gene was detected in all evaluated cases from Argentina while the wild type of the gene was seen in all the evaluable Indian cases. Our study highlights the similarities and differences in the clinical presentation and EBV association of BL in two developing countries and also indicates that the subtype of EBV and prevalence of the LMP-1 deletion may reflect the predominant subtype in a particular population.

Spinal cord compression by primary non-Hodgkin's lymphoma.

Epidural Cord Compression (ECC) by primary lymphomas is rare entity and constitutes less than 3% of total malignant lymphoma with Non-Hodgkin's Lymphoma (NHL), diffuse large cell type being the most common histological subtype. In this paper 16 cases of primary NHL with cord compression seen at the Department of Medical Oncology, during the period 1988-1990 are reviewed. At presentation all patients had undergone Laminectomy with decompression of epidural mass. The histological diagnosis of NHL was subclassified according to the International working formulation and was evaluated for disease process elsewhere in the body. All patients with ECC by lymphoma received high dose steroids with concurrent Radiotherapy (local) and combination Chemotherapy. These patients had longer duration of neurological deficit prior to treatment had poor response. After 6 courses of chemotherapy 50% of the patients had complete neurological recovery (CR), 31% had partial neurological recovery (PR) and in 19% there was no neurological recovery (NR).

Infections in the immunocompromised host: a prospective multicenter survey in patients receiving chemotherapy for acute leukemia.

Patients receiving chemotherapy for acute leukemia were prospectively followed up to determine the frequency, nature and outcome, of episodes of infection during a 6 or 12 month period at each of the participating centres. A total of 605 cycles of chemotherapy were surveyed. Of these, 490 cycles were received by patients with acute lymphoblastic leukemia (ALL) and 115 by patients with acute non-lymphoblastic leukemia (ANLL). 241 episodes of infection were recorded during the survey: 179 among ALL patients and 62 among patients of ANLL. Infections were more common during chemotherapy for ANLL than for ALL, occurring in 54% (62/115) and 36% (179/490) of chemotherapeutic cycle respectively. A favorable response to empiric antibacterial agents was seen in 39% (23/59) of episodes in ANLL patients and 77% (134/174) of episodes among ALL patients. Infection presented as fever of unidentified origin in an overwhelming majority (63%) of episodes. Gastroenteritis and pneumonia occurred with a frequency of 11% and 10% while the frequency of all other diagnoses was 3% or less. Overall, E coli and Candida were the most frequently isolated organisms while Staphylococcus aureus and Group A Streptococci were the most frequent isolates from blood and throat swabs, respectively. A high degree of resistance to commonly used antimicrobial agents was seen among the most frequently isolated organisms. About 75% of episodes of infection which did not respond to antibacterial agents responded to empiric systemic antifungal therapy; although fungi were mycologically isolated in only a quarter of these instances. Oropharyngeal candidiasis occurred in association with 3% of chemotherapeutic cycles.

Training workers and supervisors in growth monitoring: looking at ICDS.

PIP: Integrated Child Development Service (ICDS) began in India in 1975 in order to improve the nutrition and health of women and young children. It currently covers 1600 out of 5000 total blocks throughout India (1 block = 100,000 population). ICDS gives food supplements, primary health care, and nutrition education to its constituents. There is 1 Child Development Project Officer (CDPO) per block; a Mukhya Sevika (MS) -- a science graduate -- assigned to 15-20 villages; and 1 Anganwadi Worker (AWW) per village (child care). Growth monitoring is not a program objective. ICDS has conducted field and research designed to evaluate and correct its performance. Studies from 19 blocks in Gujarat and Maharshtra show the following: Not many mothers attend the education sessions or understand the concept of weighing their child. AWW's do not fill in growth charts in the mothers' presence or try to involve them in the weighing or charting procedure. Charts weren't always maintained properly. Training of workers is by and large inadequate with too much emphasis on nutritional status and not enough hands on training. ICDS is reorganizing its training program to emphasize growth and skill. In May 1986 a workshop was held by the National Institute of Public Cooperation and Child Development (NIPCCD) to give workers more relevant training through practical experience. NIPCCD developed a growth monitoring manual from the results of the workshop. The manual is divided into a concept chapter, 4 specific task chapters, and a chapter on the organization of a growth monitoring system. Training must focus on practicalities, relationships between casual factors, and hands on experience. The manual and new style of training are currently being field tested. Appendices delineate instructional objectives and guidelines for trainers.^ieng

Continuous infusion of levodopa-carbidopa intestinal gel in Parkinson's disease.

Evaluation of: Olanow CW, Kieburtz K, Odin P et al. Continuous intrajejunal infusion of levodopa-carbidopa intestinal gel for patients with advanced Parkinson's disease: a randomised, controlled, double-blind, double-dummy study. Lancet Neurol. 13(2), 141-149 (2014). Levodopa-induced motor complications, including motor fluctuations and dyskinesia, can be a major source of disability for Parkinson's disease patients. The development of levodopa-induced motor complications has been attributed to the pulsatile dopaminergic stimulation characteristic of conventional oral levodopa regimens. This is a review of a 12-week, randomized, controlled, double-blind, double-dummy study of continuous jejunal infusion of levodopa-carbidopa intestinal gel to determine if the continuous infusion of levodopa reduces motor complications in Parkinson's disease. Results demonstrated that levodopa-carbidopa intestinal gel significantly reduced off-time without increasing troublesome dyskinesia compared with standard oral levodopa therapy. Adverse effects were common in both the levodopa-carbidopa intestinal gel and placebo groups and were related primarily to the infusion hardware.