Health service COVID-19 wellbeing and support initiatives: a mixed-methods evaluation.

BACKGROUND: Health services implemented a range of initiatives during the COVID-19 pandemic to support employee wellbeing and assist employees to manage the professional and personal challenges they experienced. However, it is not known if such initiatives were acceptable to employees or met their needs. AIMS: To evaluate the wellbeing and support initiatives implemented at an Australian health service during the COVID-19 pandemic from the perspectives of employees (both users and non-users) and key stakeholders. METHODS: A mixed-methods design (survey, interviews and data audit) to investigate employees' and key stakeholders' perceptions, experiences and use of the wellbeing and support initiatives implemented at a large tertiary metropolitan health service in Melbourne, Australia. RESULTS: Ten employees participated in an interview and 907 completed a survey. The initiatives were well used and appreciated by staff. There was no significant difference in the proportion of clinical staff who had used the initiatives compared to non-clinical staff (44% versus 39%; P=0.223). Survey respondents reported the initiatives improved their mental health (n = 223, 8%), ability to cope with COVID-19 related stress and anxiety (n = 206, 79%), do their work (n = 200, 77%) and relationships with colleagues (n = 174, 67%). Staff would like many of the initiatives (with some modifications) to continue after the COVID-19 pandemic. CONCLUSIONS: The findings suggest a high level of staff satisfaction with the implemented wellbeing and support initiatives, and confirm the need for, and importance of, developing and implementing initiatives to support health service staff during outbreaks of infectious diseases such as the COVID-19 pandemic.

A Survey of Latent Tuberculosis Screening and Treatment Practices in a Tertiary Centre.

Aim Knowledge of latent tuberculosis infection (LTBI) screening and treatment practices are lacking in Ireland, where LTBI is not programmatically surveyed or managed. The aim of this research was to describe current clinical practice when screening and treating patients for LTBI in a tertiary referral centre in Ireland. Methods A 17-question survey relating to LTBI screening and management practices with both open-ended questions and close ended multiple-choice questions was created using SurveyMonkey. The survey target sample was healthcare workers in the tertiary centre who direct LTBI screening and treatment for patients at risk of TB disease in their respective departments. Results The response rate to the survey was 45% (21/47). Seventy-one percent (15/21) of those surveyed responded to the question "What barriers exist to screening patients for latent TB in your clinical practice?". Fifty-three percent (8/15) said that they found it difficult to access LTBI testing and 27% (4/15) cited accessing the interferon-gamma release assay (IGRA) result as a barrier. Forty-three percent (9/21) responded that there was not a clear referral pathway for patients that they would like specialist input on when diagnosing and managing patients with LTBI. Conclusion Access to LTBI testing, LTBI test results, TB specialist services and the use of rifamycin-based regimens should be improved in this tertiary centre. Consideration should be given to developing a national LTBI education programme for healthcare professionals and updating national LTBI treatment guidelines.

Rib fracture timing in dynamic belt tests with human cadavers.

The purpose of this article is to present data from dynamic belt loading tests on the thorax of human cadavers where the exact timing of all rib fractures is known. To quantify rib fracture timing, a total of 47 strain gages were placed throughout the thorax of two human cadavers (one male, one female). To simulate thoracic loading observed in a severe car crash, a custom table-top belt loading device was developed. The belt loading pulse was configured to result in approximately 40% chest compression during a 150 ms load and unload cycle. The time histories of each strain gage were analyzed to determine the time of each rib fracture which was then directly compared with the reaction loads and chest displacements at that exact time, thereby creating a noncensored data set. In both cadavers, all rib fractures occurred within the first 35% compression of the thorax. As a general trend, fractures on the left side of the thorax, where the passenger belt passed over the abdomen, occurred first followed by fractures to the upper ribs on the right side of the thorax. By utilizing this technique, the exact timing of each injury level can be characterized relative to the mechanical parameters. For example, using rib fractures as the parameter for Abbreviated Injury Scale (AIS) scores in the female test, it was shown that AIS 1 injury occurred at a chest compression of 21.1%, AIS 2 at 21.6%, AIS 3 at 22.0%, and AIS 4 at 33.3%.

I.V. acetaminophen pharmacokinetics in neonates after multiple doses.

BACKGROUND: Pharmacokinetics of an i.v. prodrug of acetaminophen (propacetamol) in neonates after repeat dosing are reported, with scant data for i.v. acetaminophen formulation. METHODS: Neonates from an intensive care unit received 6-hourly prn i.v. acetaminophen dosed according to postmenstrual age (PMA): 28-32 weeks, 10 mg kg(-1); 32-36 weeks, 12.5 mg kg(-1); and > or =36 weeks, 15 mg kg(-1). A maximum of five blood samples for assay and liver function tests (LFTs) were collected. A one-compartment linear disposition model (zero-order input; first-order elimination) was used to describe time-concentration profiles using population modelling (NONMEM). RESULTS: Fifty neonates, median (range) PMA 38.6 (32-45) weeks, mean (SD) weight 2.9 (0.7) kg, received a mean of 15 doses over a median 4 days with 189 serum acetaminophen and 231 LFT measurements. Standardized population parameter estimates for a term neonate were clearance (CL) 5.24 (CV 30.5%) litre h(-1) 70 kg(-1) and volume of distribution (V) 76 (29.6%) litre 70 kg(-1). CL increased with PMA from 4.4 litre h(-1) 70 kg(-1) at 34 weeks to 6.3 litre h(-1) 70 kg(-1) at 46 weeks. The presence of unconjugated hyperbilirubinaemia was associated with reduced CL: 150 micromol litre(-1) associated with 40% CL reduction. Acetaminophen concentrations between 10 and 23 mg litre(-1) at steady state are predicted after 15 mg kg(-1) 6-hourly for a neonate of PMA 40 weeks. Hepatic enzyme analysis of daily samples changed significantly for one patient whose alanine aminotransferase concentration tripled. CONCLUSIONS: The parameter estimates are similar to those described for propacetamol. There was no evidence of hepatotoxicity. Unconjugated hyperbilirubinaemia impacts upon CL, dictating dose reduction.

Working practices and job satisfaction of Victorian dental hygienists.

BACKGROUND: Increasing demand for dental services and a projected shortage in the oral health workforce in Victoria has focused attention on dental hygienists as one mechanism for increasing the supply of dental services. Understanding the dental hygienist workforce is essential in order to plan effectively for the future delivery of dental services in Victoria. METHODS: A postal survey of a random sample of Victorian dental hygienists was undertaken in 2006. Data on hygienists' demographic characteristics, current dental practice, history of career breaks, aspects of clinical practice and job satisfaction were collected. RESULTS: A response rate of 77 per cent was achieved. A total of 94.0 per cent of hygienists were currently working as a dental hygienist, working an average of 28.7 hours per week. Younger hygienists worked longer hours than their older colleagues. Career breaks were common, with 44.8 per cent reporting a career break of greater than one month, predominantly for child rearing, with a mean career break of 20.1 months. Hygienists reported a high level of satisfaction with most aspects of their employment. CONCLUSIONS: Victorian hygienists worked predominantly in private practices in metropolitan Melbourne, providing a range of preventive and periodontal services. Understanding the working patterns of dental hygienists is critical as hygienist numbers expand in the future, in order to undertake thorough evidence-based workforce planning.

Attitudes of the Victorian oral health workforce to the employment and scope of practice of dental hygienists.

BACKGROUND: Increasing the number of dental hygienists and expanding their scope of practice are two policy directions that are currently being explored to increase the supply of dental services in the context of projected oral health workforce shortages in Australia. Understanding factors relating to the employment of hygienists and the attitudes of the oral health workforce to dental hygiene practice are important in this policy debate. METHODS: A postal survey of a random sample of Victorian dentists, periodontists, orthodontists and hygienists was undertaken in 2006. Dentists and specialists were grouped into those whose practice employed or did not employ a hygienist. Data on the attitudes of dentists, specialists and hygienists towards various aspects of dental hygiene practice were explored. RESULTS: A response rate of 65.3 per cent was achieved. Hygienists believed that their employment made dental care more affordable (53.7 per cent) and improved access to dental care (88.1 per cent), while few dentists believed hygienists made care more affordable. Most hygienists believed they were capable of diagnosing periodontal disease and dental caries and formulating a treatment plan, but there was less support from employers and non-employers. Dentists were strongly opposed to independent practice for dental hygienists, although there was qualified support from employers for increasing the scope of practice for hygienists. CONCLUSIONS: Dentists who worked with hygienists acknowledged their contribution to increasing practice profitability, efficiency and accessibility of dental services to patients. Hygienists and employers supported increasing the scope of dental hygiene practice, however the majority of non-employers opposed any expansion.

Effectiveness of interferon-free therapy for the treatment of HCV-patients with compensated cirrhosis treated through the Irish early access program.

BACKGROUND: We investigated the real-world effectiveness of interferon-free regimens for the treatment of patients with compensated cirrhosis infected with hepatitis C virus (HCV). METHOD: Using the Irish national HCV treatment registry, the effectiveness and safety of interferon-free regimens for HCV-infected patients treated between April 2015 and August 2016, was determined. RESULTS: A SVR12 was achieved in 86% of subjects treated with sofosbuvir/ledipasvir ± ribavirin (SOF/LDV±RBV), 93% treated with paritaprevir, ombitasvir and ritonavir combined with dasabuvir ± ribavirin (3D±RBV) and 89% treated with sofosbuvir/daclatasvir ± ribavirin (SOF/DCV±RBV). The discontinuation rate was 5% and the on-treatment mortality rate was 1%. CONCLUSION: The availability of interferon-free regimens represents a significant breakthrough for the treatment of HCV infection. Treatments options, with high SVR12 rates, are now available for patients with compensated cirrhosis who were unsuitable for treatment with interferon-based regimens. Data obtained from studies conducted in real world practice provide robust information fundamental for input into future economic evaluations for agents used for the treatment of HCV infection.

pRotective vEntilation with veno-venouS lung assisT in respiratory failure: A protocol for a multicentre randomised controlled trial of extracorporeal carbon dioxide removal in patients with acute hypoxaemic respiratory failure.

One of the few interventions to demonstrate improved outcomes for acute hypoxaemic respiratory failure is reducing tidal volumes when using mechanical ventilation, often termed lung protective ventilation. Veno-venous extracorporeal carbon dioxide removal (vv-ECCO2R) can facilitate reducing tidal volumes. pRotective vEntilation with veno-venouS lung assisT (REST) is a randomised, allocation concealed, controlled, open, multicentre pragmatic trial to determine the clinical and cost-effectiveness of lower tidal volume mechanical ventilation facilitated by vv-ECCO2R in patients with acute hypoxaemic respiratory failure. Patients requiring intubation and mechanical ventilation for acute hypoxaemic respiratory failure will be randomly allocated to receive either vv-ECCO2R and lower tidal volume mechanical ventilation or standard care with stratification by recruitment centre. There is a need for a large randomised controlled trial to establish whether vv-ECCO2R in acute hypoxaemic respiratory failure can allow the use of a more protective lung ventilation strategy and is associated with improved patient outcomes.

Prevalence of vitamin D inadequacy in Belfast following fragility fracture.

BACKGROUND: It is well established that vitamin D levels are sub-optimal in older people and that adults with fragility fracture have low levels of serum vitamin D. OBJECTIVES: To investigate the prevalence of vitamin D inadequacy in an elderly population with fragility fractures and to compare data with previously published work from Glasgow. RESEARCH DESIGN AND METHODS: Two retrospective patient audits were carried out using records from the out-patient Osteoporosis Clinic at Musgrave Park Hospital and from in-patient hip fracture admissions at the Royal Victoria Hospital. RESULTS: There were data for 86 patients with fragility fracture from the Osteoporosis Clinic, 40.7% patients had vertebral fractures and 10.5% multiple fractures. Patients with hip fracture were excluded from the analysis. 69.8% of the patients were women. The mean age at the time of fracture was 65.3 years and 70.9% of patients were aged 60 years or over and 32.6% were aged 75 years or over. At the time of out-patient attendance, 73.3% were receiving supplementation with calcium and vitamin D. The mean vitamin D level was 52.3 nmol/L (21.0 ng/mL), SD = 23.4 (9.4). There were 83.7% of patients who had a vitamin D level < 80 nmol/L, 73.3% < 70 nmol/L and 55.8% < 50 nmol/L. There were no significant differences by patient age or sex. Data were also analysed according to supplementation status, in patients not taking supplements (n = 23) mean vitamin D level was 48.1 nmol/L (19.3 ng/mL), SD = 27.4 (11.0) compared with 53.8 nmol/L (21.6 ng/mL), SD = 21.8 (8.7) in the 63 patients taking supplements. Prevalence of inadequacy was higher in the patients not taking supplements 82.6% versus 67.1% at the 70 nmol/L threshold. There were data for 43 hip fracture patients, 95.3% of the patients were women. The mean age at the time of fracture was 78.3 years, 95.3% of patients were aged 60 years or over and 69.8% were aged 75 years or over. Data were not available on whether these patients were receiving supplementation. The mean vitamin D level was 36.1 nmol/L (14.5 ng/mL), SD = 24.8 (9.9). 90.7% of patients had a vitamin D level < 80 nmol/L, 88.4% < 70 nmol/L ( approximately 28 ng/mL) and 88.4% < 50 nmol/L ( approximately 20 ng/mL). CONCLUSIONS: The levels of vitamin D inadequacy revealed in this audit were similar to those in an earlier audit carried out in Glasgow. Thus studies at two locations in the UK confirm the high prevalence of vitamin D inadequacy, furthermore, the prevalence of inadequacy appears to be higher in those patients with a hip fracture.

Prior feeding alters the response to the 50-g glucose challenge test in pregnancy. The Staub-Traugott effect revisited.

OBJECTIVE: To examine the effect of prior meal ingestion on the glucose, insulin, and C-peptide response to a 50-g glucose challenge test in the third trimester of pregnancy. RESEARCH DESIGN AND METHODS: Ten pregnant women with gestational diabetes mellitus and 12 nondiabetic pregnant control subjects matched for age and weight underwent a 50-g glucose challenge test on three occasions within a 2-wk period, in random order. On one occasion the test was administered in the fasting state (fasting glucose challenge test), on a second occasion the test was administered 1 h after ingestion of a standard mixed meal (1-h postprandial study), and on a third occasion the test was administered 2 h after ingestion of a standard mixed meal (2-h postprandial study). RESULTS: In the control subjects, the plasma glucose level 1 h after ingestion of 50 g of glucose was higher in the fasting study (7.8 +/- 0.4 mM, 7 of 12 subjects with glucose > or = 7.8 mM) than in the 1-h postprandial study (6.7 +/- 0.3 mM, 3 of 12 subjects with glucose > or = 7.8 mM) and the 2-h postprandial study of (6.3 +/- 0.4 mM, 3 of 12 with glucose > or = 7.8 mM) (P < 0.01). In the postprandial studies of control subjects, insulin and C-peptide levels were higher at the time of ingestion of the 50 g of glucose, but the early (1 h) insulin secretory response was less than in the fasting study. In the diabetic patients, glucose levels 1 h after 50-g glucose ingestion were similar in the fasting study (10.5 +/- 0.4 mM, no subjects with glucose value < 7.8 mM) and the 1-h postprandial study (11.0 +/- 0.6 mM, 1 subject with glucose < 7.8 mM), but was lower in the 2-h postprandial study (9.3 +/- 0.3 mM, 1 subject with glucose < 7.8 mM) (P < 0.03). In contrast to the control subjects, the insulin secretory response to 50 g of oral glucose was greater in the two postprandial studies than in the fasting study. CONCLUSIONS: We have reached the following conclusions. 1) In nondiabetic gravidas, plasma glucose concentrations 1 h after ingestion of a 50-g oral glucose load are higher if administered in the fasting state compared with the postprandial state. 2) During normal pregnancy the Staub-Traugott Effect, i.e., improved glucose disposal after successive glucose load administrations, occurs and appears to be caused by mechanisms other than enhanced insulin secretion with successive glucose loads. 3) The effect of the prandial state on plasma glucose response to the 50-g glucose challenge test used to screen for gestational diabetes mellitus may be of sufficient magnitude to significantly alter the operating characteristics, i.e., sensitivity and specificity, of this test.

Gastric rupture following nasopharyngeal catheter oxygen delivery-a report of two cases.

Iatrogenic gastric distension and subsequent rupture following nasal or nasopharyngeal catheter oxygen delivery is a rare but life-threatening condition that requires urgent laparotomy. We report two cases recently encountered at our institution. Both patients exhibited symptoms of abdominal pain and distension following oxygen delivery involving a nasopharyngeal catheter during procedural sedation. Oxygen flow rates were 4 l/minute in both cases. The diagnosis was made by urgent imaging. Both patients survived following laparotomy and repair of gastric rupture. Seventeen cases have been reported previously in the literature. We recommend avoidance of nasal or nasopharyngeal catheters and the use of alternative oxygen delivery methods such as nasal prongs and face masks.

Clinical assessment and follow-up of functional capacity in patients with chronic congestive cardiomyopathy.

The presumption that the results of left ventricular systolic function tests performed at rest are related to the symptoms of chronic congestive heart failure or to exercise capacity is unproved. Thirty-three patients with chronic congestive cardiomyopathy underwent serial exercise tests, determinations of ejection fraction and systolic time intervals, echocardiograms, assessment of symptom score, chest roentgenogram, and physical examination over a mean ( +/- standard deviation) of 24.8 +/- 14.1 months. Maximal exercise performance achieved correlation with symptoms (r = 0.66) but not with indexes of left ventricular function. Edema, elevated jugular venous pressure, rales and radiologic evidence of pulmonary venous hypertension were more common in patients with severe limitation of exercise capacity. in 17 patients whose functional capacity changed during the follow-up period, congruent changes in left ventricular function measured at rest were not consistently observed. Thus the findings on history, physical examination and radiologic examination correlate with exercise capacity, but indexes of left ventricular performance at rest do not and therefore are of limited use in assessing treatment. The clinical course of patients with chronic congestive cardiomyopathy can be followed up safely, effectively and economically by simple clinical observations. Serial laboratory testing of left ventricular function can be reserved for specific indications, research and patients with valvular heart disease.

Cell free serum interleukin-2 receptor levels after heart transplantation.

The aim of this study was to predict episodes of rejection or infection in heart transplant recipients by monitoring serum interleukin-2 receptor (IL-2R) levels, rather than by endomyocardial biopsy. The shedding of IL-2R from activated lymphocytes results in increased serum interleukin-2 levels and is probably a result of immune activation occurring in both rejection and infection processes. As a group, heart transplant recipients who had no rejection of infection had significantly increased serum IL-2R levels compared with healthy controls. Patients who had moderate and severe rejection, and infection, had significantly increased serum IL-2R levels compared with levels in patients without rejection or infection. High serum IL-2R levels were seen mainly within the first 3 months after transplantation. Of 15 patients studied, nine had consistent increases in serum IL-2R levels with episodes of rejection or infection. Serum IL-2R levels did not correlate with serum cyclosporine levels. The monitoring of serum IL-2R levels was not a sensitive test of rejection because increases were not seen in all episodes of rejection; increases were seen, however, in all cases of infection. This test lacked specificity as serum IL-2R levels increased during episodes of both rejection and infection. In conclusion, the monitoring of serum IL-2R levels may be a useful way to routinely monitor or screen for possible rejection infection in heart transplant recipients, but this method should not replace endomyocardial biopsy for diagnosing rejection.

The effects of exercise and weight loss on plasma lipids in young obese men.

We studied the independent and combined effects of exercise training and weight loss on blood lipids under fixed diet and exercise conditions. Twenty-one obese sedentary men were randomly allocated to one of four treatment groups: (1) inactive and constant weight (control), (2) exercise training and constant weight, (3) inactive and weight loss, and (4) exercise training and weight loss. There were three study periods: a 3 week baseline period inactive and on an isocaloric diet, a 12 week treatment period, and a 3 week weight stabilization period. Exercise consisted of treadmill walking at an energy cost of 3500 kcal/wk for groups 2 and 4 with replacement caloric intake only in group 2. Group 3 reduced caloric intake by 3500 kcal/wk during the treatment period. Weight loss for groups 3 and 4 were 13.4 pounds and 13.7 pounds, respectively. Maximal oxygen uptake (mL/min) increased 6% in both exercise groups (2 and 4), and percent body fat decreased only in these groups. Regression analysis by group assignment on HDL cholesterol (HDL-C) showed that the inactivity-weight loss modality (group 3) and the exercise-constant weight modality (group 2) each significantly increased HDL-C, with an additive effect of exercise and weight loss (group 4). The rate of HDL-C change differed significantly between groups (P = 0.01). HDL-C increased 0.63, 0.61, and 1.89 mg/dL per 3 weeks or 2%, 2.4%, and 5.5% above baseline levels in groups 2, 3, and 4, respectively, while the control group decreased 0.11 mg/dL. Plasma triglycerides and very low-density lipoprotein (VLDL) cholesterol increased with exercise at constant weight (group 2) and decreased with exercise associated with weight loss (group 4). In conclusion, exercise and weight loss separately and independently increase HDL-C, and their effects are additive.

Value of noninvasive studies in community-acquired pneumonia.

Noninvasive diagnostic studies, i.e., sputum gram stain, sputum culture, blood culture and antigen detection assays will assist the clinician in the selection of initial antimicrobial therapy in some patients. These tests may be even more valuable in adjusting treatment regimens to prevent the use of broad spectrum antimicrobial agents as routine therapy.

Potential importance of Legionella species as etiologies in community acquired pneumonia (CAP).

Large percentages of patients with community acquired pneumonia (CAP) do not have a defined etiology. Between 1992-1993, 99 acute and convalescent sera were collected from patients with CAP of unknown etiology. The sera were tested using an indirect immunofluorescence antibody assay (IFA) against the following antigens: Legionella pneumophila, serogroups 3,5,6 and 7 and L. longbeachae, L. anisa, L. bozemanii and Legionella-Like Amoebal Pathogens (LLAP). A four-fold rise in titer to at least one of the antigens tested, was seen in 14% of patients; 8% to L. bozemanii, 4% to L. anisa, 2% to S. lyticum, 2% to LLAP 10 and 1% each to LLAP 1, 6 and 9. Two patients reacted to several antigens. These results indicate that other species of legionella may be important in the etiology of CAP. L. bozemanii was the organism identified in the majority of these infections. Better diagnostic studies i.e. cultures, serologies and urinary antigen testing, which recognize legionella isolates other than L. pneumophila serogroup 1 need to be developed.

Blood lipid effects of antihypertensive therapy: a double-blind comparison of the effects of methyldopa and propranolol.

Thirty-two middle-aged men with essential hypertension completed a double-blind randomly allocated comparison of the effects of methyldopa versus propranolol on blood lipid levels. After a four-week period on a placebo for each drug, subjects were titrated for the next six weeks with either methyldopa from 500 to 2000 mg/day or propranolol from 80 to 320 mg/day plus a placebo for the other drug until supine diastolic blood pressure was below 90 mm Hg or the ceiling dose was reached. Subjects were then maintained on the achieved drug dose for an additional six weeks and finally switched back to a placebo for each drug for four more weeks. Blood lipid levels were measured twice during each study period and the values averaged and compared. Neither drug significantly affected levels of total plasma cholesterol. However, both drugs reduced high-density lipoprotein (HDL) cholesterol levels about 10 per cent and increased the total cholesterol to HDL cholesterol ratio. In addition, propranolol significantly increased plasma triglyceride levels (28.3 per cent). The changes in lipid levels were not dose related. Whether or not these blood lipid changes persist and their possible clinical implication during prolonged therapy remain to be elucidated.

Efficacious response with lower dose indapamide therapy in the treatment of elderly patients with mild to moderate hypertension.

A low dose (1.25 mg) of indapamide (Lozol, Rhône-Poulenc Rorer Pharmaceuticals, Collegeville, PA) was evaluated in 222 elderly patients (> or = 50 years) with mild to moderate essential hypertension in a multicenter, randomized, double-blind, parallel-group clinical trial. A 4-week single-blind placebo washout period was followed by an 8-week double-blind treatment period. Patients were randomized to receive indapamide 1.25 mg/day or to receive placebo. The primary efficacy variable was the mean change in sitting diastolic blood pressure from baseline to week 8. Eighty-one patients in the indapamide group (73%) and 87 patients in the placebo group (78%) completed the 8 weeks of double-blind therapy. Therapy with 1.25 mg of indapamide produced greater reductions compared with placebo in sitting diastolic blood pressure after 8 weeks of therapy, with statistical significance (P < or = 0.0015) seen after only 2 weeks of therapy and continuing throughout the 8 weeks. All secondary efficacy measures (sitting systolic blood pressure, standing systolic and diastolic blood pressures, and > or = 10 mm Hg decrease or final value of < or = 90 mm Hg in sitting diastolic blood pressure) also showed superior (P < or = 0.0014) improvement in the indapamide group compared with placebo after 8 weeks of double-blind treatment. During the 8-week double-blind treatment period, incidence rates for all adverse events and for drug-related adverse events were similar between the two treatment groups.(ABSTRACT TRUNCATED AT 250 WORDS)