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Although few cases were considered serious buy female cialis 20mg overnight delivery menopause cures, withdrawals secondary to edema were common cheap female cialis 10mg online pregnancy week by week. Both pioglitazone and rosiglitazone were associated with higher rates of edema than placebo; the between-group difference (in favor of placebo) was 0% to 3 order female cialis 10 mg on-line menstruation kids. Richter and colleagues did a similar review of rosiglitazone and noted an odds ratio for edema of 4 cheap female cialis 20mg mastercard menstruation pain relief. These authors attempted to compare the rates with rosiglitazone and pioglitazone and found the rates higher with rosiglitazone (odds ratio 3. Hypoglycemia Hypoglycemia was fairly uncommon with both thiazolidinediones. The combination of insulin 89, 120, 212 and a thiazolidinedione increased rates of hypoglycemia. Hypoglycemia rates with 89, 119, 120 thiazolidinediones were lower than rates with sulfonylureas. Thiazolidinediones cause less hypoglycemia than second generation sulfonylureas, with risk differences ranging between 0. Rates with metformin were 89 similar to those with thiazolidinediones (obtained from indirect comparisons). They conducted a meta-analysis of 17 randomized control trials comparing a TZD with placebo or active control. Four of these studies reported results for hypoglycemic events. The risk of experiencing nonsevere hypoglycemia with TZD use compared with other treatments was not statistically significant (odds ratio 1. They found that there was no statistically significant increased risk of hypoglycemia with TZDs (RR 2. Elevated serum aminotransferase levels 89 Bolen and colleagues found that rates of significant increases in serum aminotransferase levels (> 1. Other systematic reviews reached similar conclusions. Weight change Thiazolidinediones caused similar weight gain compared with sulfonylureas either as mono- or combined therapy. Metformin consistently caused weight loss compared with thiazolidinediones 89 and other oral agents. These authors identified 2 head-to-head randomized controlled trials and noted similar increases in weight with pioglitazone and rosiglitazone. Data from 5 studies with sufficient data on change in weight from baseline, showed that TZD use was associated with a statistically nonsignificant increase in weight (weighted mean difference 1. When 3 trials comparing a TZD to an insulin secretagogue or muraglitazar were removed from the analysis, TZDs were associated with a statistically significant increase in body weight (weighted mean difference 2. Fractures One systematic review that analyzed data on the occurrence of fractures among patients using 204 TZDs met our inclusion criteria. It reported a statistically significant increased risk of fracture among patients who were exposed to rosiglitazone and pioglitazone (odds ratio 1. The analysis was based on 10 randomized controlled trials involving 13,715 participants. The authors reported a significantly increased risk of fractures among women (odds ratio 2. The review concluded that long-term use of TZDs doubles the risk of fractures among women with type 2 diabetes, without a significant increase in risk among men. Other reviews In addition to the systematic reviews identified for the previous Drug Effectiveness Review Project TZDs report, 2 reviews were described (See Evidence Table 1 for 2008 TZD Report) in the previous Drug Effectiveness Review Project TZDs report that were not systematic and 214, 215 therefore did not fulfill inclusion criteria for the previous report. We found 1 additional 216 review that used the same dataset from the review by Nissen et al. This paper was not determined to be a systematic review and therefore did not fulfill inclusion criteria. Evidence of a comprehensive literature search and data synthesis was not provided in the publication. Two large trials (DREAM and ADOPT) were the only included trials from the published literature. The authors noted an odds ratio for myocardial infarction of 1. The primary composite endpoint (death, nonfatal myocardial infarction, and nonfatal stroke) was decreased with pioglitazone as mono- or combination therapy with a variety of antidiabetic drugs (hazard ratio 0. For placebo-controlled trials the hazard ratio was 0. The risk of serious heart failure was increased with pioglitazone (hazard ratio 1. Direct evidence: Pioglitazone compared with rosiglitazone head-to-head trials 92, 93 90, 99-102 92 Eight head-to-head efficacy trials with adverse event data were identified. In one, 719 patients with both type 2 diabetes and dyslipidemia were randomized to treatment with pioglitazone 30 mg daily for 12 weeks followed by 45 mg for an additional 12 weeks, or rosiglitazone 4 mg daily followed by 8 mg for the same intervals. There were no differences between the drugs in adverse events including weight change (2. Data on the incidence of specific adverse events were not reported. A second study included patients who were switched to pioglitazone or rosiglitazone 93 from troglitazone. There was no information reported about adverse events in this study, with the exception of a similar weight gain in both groups (data not reported). Of the 87 patients (96%) who completed the study, 6. There were no significant differences between treatment groups in serum alanine (ALT) or aspartate (AST) aminotransferase at 12-month follow-up. In 1 subject in the pioglitazone group (N=45) ALT and AST increased to 1. One of the head-to-head studies identified for the updated report (2008) presented both 94-96, 142 tolerability and adverse events data. Derosa and colleagues noted among study completers (93% completion rate) that the rate of any side effect was 8. These adverse events were transient headache and flatulence (metformin was new to 98 some of the study subjects). In this trial, there were no significant differences between treatment groups in ALT or AST at 12-month follow-up. In 2 subjects in the pioglitazone group (N=48) ALT and AST increased to 1. With rosiglitazone (N=48) in 3 subjects AST and ALT increased to 2. No other adverse events were reported in this study. Hematocrit decreased significantly in both treatment groups (P<0. Briefly, all 4 of these were small studies (Numbers of 12, 35, 50, and 60) ranging from 12 to 20 weeks and were not designed to assess harms. Three of them reported slightly greater 99, 101, 102 improvements in some lipid measures with pioglitazone than with rosiglitazone. Indirect evidence For this report, we did not update the comparisons of pioglitazone or rosiglitazone compared with placebo. This information was included in the 2008 Drug Effectiveness Review Project 18 drug class review on TZDs. We briefly summarize the findings of that report here. Overall withdrawals 160, 163-165, 177, 180, 218-220 166, 167, Nine placebo-controlled trials of pioglitazone and 16 of rosiglitazone 169-172, 176, 221-232 reported overall withdrawal rates. Treatment group withdrawal rates ranged from 7% to 33% in pioglitazone trials and 0 to 28% in rosiglitazone trials. Pooled risk differences showed trends for lower overall withdrawals in treatment groups than placebo groups for both pioglitazone (−1. There was significant heterogeneity among rosiglitazone trials. Withdrawals due to adverse events 18 The previous Drug Effectiveness Review Project TZDs report found that the proportion of patients who withdrew due to adverse events was similar for the 2 drugs: 4. Pooled risk differences showed no differences from placebo in either pioglitazone (0%; 95% CI −2 to 2) or rosiglitazone (−1%; 95% CI −3 to 0) trials. The proportion of withdrawals due to adverse events in the placebo groups differed between these groups of studies (4. Specific adverse events reported in placebo-controlled trials 18 The previous Drug Effectiveness Review Project TZDs indicated that the quality of reporting of adverse events in randomized controlled trials designed to measure efficacy was fair to poor. Most studies did not prespecify which events were evaluated and did not report details about ascertainment methods. In most cases, there was no difference from placebo in the number of patients reporting an adverse event. The most frequently reported adverse events were edema, hypoglycemia, and weight gain. Edema The incidence of edema reported in 16 placebo-controlled trials ranged from 0% to 27%. The incidence of edema was significantly greater with both pioglitazone and rosiglitazone than placebo. The pooled risk difference was significantly greater than placebo in pioglitazone trials (4%, 95% CI 2 to 7).

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RARE ENTITIES As you can see correct epidemiological data is Phyllodes tumor (benign form described in Chapter important for making a case for breast cancer treat- 25) is a very fast growing entity derived from the ment as a priority in health resource planning buy female cialis 10 mg overnight delivery breast cancer wallpaper. A sarcoma is an aggressive tumor that develops from muscular cells cheap 20 mg female cialis amex womens health hotline. Beware that also CLINICAL PRESENTATION AND COURSE malignant non-Hodgkin lymphomas may occur in the OF DISEASE breast order female cialis 10 mg online women's health clinic ucf. Mammary Paget disease of the breast consists of malignant cells confined to the nipple and areola cheap female cialis 10 mg free shipping women's health issues 2013. To estimate the extent of the disease the tumor has An underlying breast cancer may be present! The most recent 6th TNM classification provides the world standard for clinical and pathological staging12. MAGNITUDE OF THE PROBLEM IN LOW- The invasive tumor itself is documented as cT RESOURCE SETTINGS (clinically) or pT (pathologically) or ypT (through As many regions of the world don’t have national histology after neoadjuvant chemotherapy) – simi- cancer registries incidences are difficult to assess. Figures from India show a rise in incidences for many regions. Box 2 TNM classification Rates have been doubling in the past 40 years in T for tumor size (add a small c, p or yp before the Japan, Korea and Singapore. In China incidences T depending on method of assessment): rose 20–30% in the past 10 years and are rising 2% T0 no tumor detectable per year in India. It is notable that almost 50% of Tis carcinoma in situ, non-invasive the cases occur in pre-menopausal women. In T1 up to 2cm Lebanon, 49% of the patients are less than 50 years 10 T1a ≤ 0. IX from IARC/WHO), these T4 any size including invasion of chest wall trends are difficult to evaluate for their correctness or skin or both and underlying causes. Breast cancer in low-resource settings has a N for lymph node involvement: much higher mortality (7 out of 10 newly diag- N0 none nosed with breast cancer die) as compared with N1 1–3 in the axilla high-resource settings (2 out of 10 die)2. High N2 4–9 in the axilla mortality might have two reasons: first, many N3 10 or more in the axilla or below/above patients in those countries present with advanced- clavicle stage disease due to lack of awareness, barriers to M for metastasis: seeking care early and unskilled healthcare workers. M0 none (this will always be a clinical For these women prognosis is poor and disease-free diagnosis cM0 – do not write pM0) survival short. Second, in those regions resources M1 distant metastasis present (may be cM1, for healthcare are limited and are mostly put in the e. But 369 GYNECOLOGY FOR LESS-RESOURCED LOCATIONS The classification is needed for documentation and Clinical breast examination (BHGI level 1) statistics but even more to assess the patient, decide Clinical breast examination (CBE) can be used in a on therapy and estimate prognosis! The Make sure to find out more about the family his- CBE of the latter is called opportunistic. Also endometrial, should offer CBE to all your at-risk clients once ovarian and colorectal cancer may be associated yearly or at any visit according to BHGI, as it is a with breast cancer. On the other hand, patients cost-effective method for screening in order to with a genetic mutation for breast cancer have a detect early stage breast cancer13,14. Please refer to higher risk of developing ovarian cancer. The social circumstances are important as the dis- It is important to remember that you should always ease will surely affect all aspects of the woman’s life. Please refer to Chapters 1 and 16 for mastitis but bear in mind that the average patient details of history taking in breast disease. To improve your detection rates and avoid false- Inspection (patient seated) In a symptom-free patient negative or -positive diagnosis you should always look for differences in size and form of both breasts correlate your results from history taking, clinical and nipples (Figure 3). Look for areas with swollen examination, imaging findings and cytology/histo- skin resembling the skin of an orange. This may be logy for the likelihood of the results (this is called a sign for tumor invasion of the lymphatic vessels of triangulation) (Figure 2). Your investigations will the skin (orange skin phenomenon) – or otherwise help in making the diagnosis of breast cancer and as- it may indicate inflammation (see Figure 1 in Chap- sessing the stage of disease which will influence ther- ter 25). Look for bulging tumors, skin rashes of the apy options for your patient. Thus you have to breast or the nipples and for induration or retrac- evaluate the patient’s breast for local disease and if tion of the skin (plateau phenomenon). When chemotherapy is available at the basic level, these tests should also be provided. When tamoxifen is available at the basic level, IHC testing of ER status should also be provided. In this case, measurement of HER-2/neu overexpression and/or gene amplification would also need to be available at the limited level in order to properly select patients for this highly effective but expensive HER-2/neu-targeted biological therapy. Note that the table stratification scheme implies incrementally increasing resource allocation at the basic, limited and enhanced levels. Maximal resources level should not be targeted for implementation in low- and middle-income countries, even though they may be used in some higher income settings. Guideline implementation for breast healthcare in low-income and middle-income countries: overview of the Breast Health Global Initiative Global Summit 2007. This material is reproduced with permission of Wiley-Liss, Inc. Old Then look for swollen lymph nodes in axilla, women can get breast cancer as well so it is very around the neck and the clavicles. Inspect the important to explain this to your old clients, offer margins of the ulcer if the patient comes with an them CBE and teach them how to do SEB as well. You may take a swab for cytology Make sure the woman understands why to do SEB. Tuberculosis or lymphoma of the breast can be be able to note the following changes: seen in patients with advanced HIV disease (see 1. A breast lump that feels different from the sur- Figure 7 in Chapter 25). Bloody discharge from the nipple Examination (patient seated) Check the patient’s 3. Change in the size or shape of a breast axillae for swollen lymph nodes as described in 4. Changes to the skin over the breast, such as Chapter 1. Then palpate the neck region for swollen dimpling lymph nodes on both sides. Inverted nipple (a nipple turned inward into the tumor is fixed to the skin or the underlying pec- the breast ) toral muscle. Peeling or flaking/swelling of the nipple or much more easily, a fixed mass may not be operable areola skin at all (Figure 3c). Redness or pitting of the skin of breast, like the is any kind of discharge (milky fluid, clear fluid or skin of an orange blood) (see Figure 3 in Chapter 25). Milky discharge is quite common in women who have breastfed. The idea of the examination is that the women will investigate all areas of both breasts. Inspection is convenient in front of a mirror – Self-examination of the breast (BHGI level 1) with arms hanging down, on the waist and up in There is no evidence that self-examination of the the air. Any skin or nipple changes, any change in breast (SEB) leads to a reduced mortality from shape, redness or suspicion of a lump may be noted. The large ‘Shanghai trial’ did not find Palpation may be done in a concentric or ‘up and differences in breast cancer mortality between the down’ manner – making sure to reach all areas. Use three fingers – not only the finger evidence 1b). The procedure may take 20 min while com- experts that SEB will raise women’s awareness of fortably lying on the back. It is essential to cover their breasts and therefore promote breast health! The procedure should include deeper and how to examine their breasts themselves once a more superficial palpation of the breast tissue. A Palpating in different positions (on the side, stand- pre-menopausal woman should do the examina- ing and sitting) may add information. After a while tion on a specific day in the first week after her the women will know about her breasts and notice period started; let’s say on day 4 or 5. The website of the Inter- tant as hormonal changes after or around ovulation national Agency for Research on Cancer (IARC) make the breast difficult to assess. This is why it is gives good instructions on how to do SBE (http:// important to ask about her period as well when you screening. You might need to call her back to re- check your findings after her period if in doubt. General physical examination (BHGI level 1) A postmenopausal woman has no hormonal changes influencing her breasts anymore and no In a patient with early breast cancer a general period to remember SEB. So you should recom- examination will usually provide no important 373 GYNECOLOGY FOR LESS-RESOURCED LOCATIONS findings as the likelihood for metastasis is small. But for swollen inguinal lymph nodes and swollen legs. This will have an impact on her survival or how well she will tolerate therapy, especially chemo- Ultrasound (BHGI level 2) therapy as this will influence her immune system. It is nevertheless especially important to do gen- Mammography is the gold standard for screening eral examination for patients with advanced disease and assessment for breast cancer in developed coun- as they are more likely to have metastasis. Often it is not available in a low-resource set- with metastasizing breast cancer cannot be cured – ting. Using ultrasound has several advantages for the palliative care is needed. Many breast cancer patients in to look thoroughly for metastasis as this will influ- low-resource settings are pre-menopausal. Breast cancer most breast tissue is often very dense and thus suspicious frequently spreads to the lymph nodes, lungs, the lesions may be better evaluated with ultrasound liver and the bones and to the brain.

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Mortality 28 cheap female cialis 10mg menstruation 6 weeks after birth, 46 discount female cialis 10mg otc women's health magazine old issues, 52 purchase female cialis 20mg mastercard breast cancer in males, 53 46 Few reviews examined mortality (total or cardiovascular) buy female cialis amex menstruation 40 day cycle. Eurich and colleagues examined the use of various antidiabetic agents in patients with heart failure and diabetes and identified 3409 thiazolidinedione-treated subjects. Pooled odds ratios for thiazolidinediones compared with other hypoglycemic agents for all-cause mortality was 0. Pioglitazone and rosiglitazone were combined in the studies contributing to these pooled effects. These authors note that the finding of lower all-cause mortality with thiazolidinediones should be interpreted with caution, as 3 of the 4 studies contributing to this estimate were observational in design, and subjects receiving these drugs may have been at lower risk for heart failure due to the commonly perceived risk of using them among persons with higher risk of cardiovascular events and congestive heart failure. In 4 trials, the relative risk for all- cause mortality was 0. Cardiovascular mortality rates were similar to all-cause rates (RR 0. Both of the reviews included active drug and placebo comparisons, and only the randomized controlled 56 trial by Dargie was included in both the reviews. In a systematic review of thiazolidinedione use in subjects who underwent coronary stent implantation, at 6-month follow-up mortality rate was 2/259, a death in each the control and 52 28 rosiglitazone arms. Bolen and colleagues did not identify sufficient studies examining mortality to permit calculation of a pooled estimate. Cardiovascular morbidity Only 3 reviews examined the effects of thiazolidinediones on cardiovascular events; 2 focused 50, 53 28 on rosiglitazone and the third on both thiazolidinediones. Richter and colleagues only 57 53 identified data from ADOPT (discussed below). Singh, Loke, and Furburg identified 3 56-58 randomized controlled trials in type 2 diabetes, all of which were included in this update. Pooled estimates were obtained for these 3 randomized controlled trials and the DREAM trial of 59 persons with prediabetes. These studies compared various drugs at a variety of follow-up intervals, although statistical tests for heterogeneity were not significant by usual criteria. The Thiazolidinediones Page 21 of 193 Final Report Update 1 Drug Effectiveness Review Project relative risk for myocardial infarction of rosiglitazone compared with other drugs was 1. Three randomized controlled trials comparing thiazolidinediones and metformin and 2 randomized controlled trials comparing thiazolidinediones and sulfonylureas reported similar rates of nonfatal myocardial infarction or coronary heart disease between the thiazolidinedione and the comparison drug. Five short- duration, placebo-controlled studies also found similar rates of cardiovascular disease events and 60 the PROACTIVE placebo-controlled trial also demonstrated no significant difference. Three randomized controlled trials examining restenosis rates noted fewer cardiovascular disease events with thiazolidinediones than with placebo in patients at high risk. Congestive heart failure 53 In a review of persons with diabetes or prediabetes using rosiglitazone, the relative risk of heart failure for rosiglitazone compared with various other antidiabetic drugs was 2. The odds ratio for all heart failure adverse events was 2. These authors also examined case reports, including 162 case subjects with 99 analyzable cases. Among these cases, the median time to onset of congestive heart failure was 24 weeks, although failure could occur early and did not appear to relate to dosage. Heart failure was not limited to the elderly; 26% of cases were in subjects less than 60 years of age. Hospital admission for heart failure was elevated with thiazolidinediones compared with other treatments (pooled odds ratio 1. For placebo-controlled trials only, the relative risk was 1. When examined separately, the relative risk for pioglitazone was 1. The overall event rate for congestive heart failure with thiazolidinediones was 2. The number needed to harm for congestive heart failure was 107 over the 29. Although the risk of heart failure was increased, the risk of cardiovascular death was not significant: relative risk 0. Edema 28 Bolen and colleagues noted that the risk for edema was higher with thiazolidinediones than metformin or second generation sulfonylureas. Although few cases were considered serious, withdrawals secondary to edema were common. Both pioglitazone and rosiglitazone were associated with higher rates of edema than placebo; the between-group difference (in favor of placebo) was 0% to 3. Richter and colleagues did a similar review of rosiglitazone and noted an odds ration for edema of 4. These authors attempted to compare the rates with rosiglitazone and pioglitazone and found the rates higher with rosiglitazone (odds ratio 3. Hypoglycemia Hypoglycemia was fairly uncommon with both thiazolidinediones. The combination of insulin 28, 51, 61 and a thiazolidinedione increased rates of hypoglycemia. Hypoglycemia rates with 28, 50, 51 thiazolidinediones were lower than rates with sulfonylureas. Thiazolidinediones cause less hypoglycemia than second generation sulfonylureas, with risk differences ranging between 0. Rates with metformin were similar 28 to those with thiazolidinediones (obtained from indirect comparisons). Elevated serum aminotransferase levels 28 Bolen and colleagues found that rates of significant increases in serum aminotransferase levels (> 1. Other systematic reviews reached similar conclusions. Weight change Thiazolidinediones caused similar weight gain compared with sulfonylureas either as mono- or combined therapy. Metformin consistently caused weight loss compared with thiazolidinediones 28 and other oral agents. These authors identified 2 head-to-head randomized controlled trials and noted similar increases in weight with pioglitazone and rosiglitazone. Other reviews In addition to the systematic reviews identified for the updated report, we identified 2 reviews 62, 63 (Appendix G) that were not systematic and therefore did not fulfil our inclusion criteria. This paper was not a systematic review and therefore did not fulfil inclusion criteria for this report. Evidence of a comprehensive literature search and data synthesis Thiazolidinediones Page 23 of 193 Final Report Update 1 Drug Effectiveness Review Project was not provided in the publication. Two large trials (DREAM and ADOPT) were the only included trials from the published literature. These authors noted an odds ratio for myocardial infarction of 1. The primary composite endpoint (death, nonfatal myocardial infarction, and nonfatal stroke) was decreased with pioglitazone as mono- or combination therapy with a variety of antidiabetic drugs (hazard ratio 0. For placebo-controlled trials the hazard ratio was 0. The risk of serious heart failure was increased with pioglitazone (hazard ratio 1. For persons with type 2 diabetes, do pioglitazone and rosiglitazone differ from each other, from placebo, and from other oral hypoglycemic agents in the ability to reduce and maintain A1c levels? Summary of the Evidence Pioglitazone compared to rosiglitazone: • Prior systematic reviews found both drugs appear to have similar effects on A1c, producing a decrease of approximately 1%, similar to the change produced with other oral agents (including metformin, glibenclamide, or glimepiride). Thiazolidinediones compared to other oral hypoglycemic agents: • In a prior systematic review, there were no between-group differences between thiazolidinediones and metformin (7 randomized controlled trials) or second- generation sulfonylureas (13 randomized controlled trials). Thiazolidinediones Page 24 of 193 Final Report Update 1 Drug Effectiveness Review Project Detailed Assessment Head-to-head trials Three fair-quality, head-to-head, randomized controlled trials (in 4 publications) were identified 65-68 examining persons with type 2 diabetes (Table 4 and Evidence Table 3). Quality assessment of all trials is shown in Evidence Table 4. Two randomized, controlled, double-blind trials 65 67 demonstrated significant improvements in A1c at follow-up with no significant differences 68 between groups. In an open-label trial, Kahn and colleagues noted no significant change in A1c in either group when the study drugs were used after troglitazone was discontinued with a 2- week wash-out period. We also 71 65, 66 identified a new companion paper to a trial included in the original report. The companion paper did not provide any additional relevant information or outcomes; rather it focused on lipoprotein (a) and homocysteine concentrations. Derosa and colleagues published a new study comparing pioglitazone and rosiglitazone, 70, 72-74 both combined with metformin 1500-3000 mg daily. The second head-to-head study identified for the updated report was a small, poor- quality, cross-over study (N=17) comparing rosiglitazone and pioglitazone among persons with type 2 diabetes, and no significant difference between groups was noted for A1c (P=0. Thiazolidinediones Page 25 of 193 Final Report Update 1 Drug Effectiveness Review Project Table 4. Head-to-head trials comparing pioglitazone with rosiglitazone in persons with type 2 diabetes A1c (%) baseline; Follow-up; Change from Study Combination Other baseline Quality; Sample size Dosages therapy characteristics (mean, SD) Funder Pio 30-45 Pio: 7. In view of the paucity of data allowing direct comparisons between pioglitazone and rosiglitazone for the outcome of A1c, we proceeded with an examination of placebo-controlled trials allowing indirect comparisons. Placebo-controlled trials of pioglitazone In the original report, we identified 16 trials comparing pioglitazone to placebo in at least 1 study arm (Table 5 and Evidence table 5). All but 1 of these trials had sufficient data to permit a meta- 76 analysis (Figure 2); a study by Saad and colleagues did not provide a measure of dispersion. The mean difference between groups for all good- and fair-quality studies comparing pioglitazone with placebo ranged from -3. In other words, overall, pioglitazone improved A1c about 1. Heterogeneity among these studies was Thiazolidinediones Page 26 of 193 Final Report Update 1 Drug Effectiveness Review Project significant (P<0.

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