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Cyproheptadine

By E. Peratur. York College of Pennsylvania. 2018.

Gestational trophoblastic tumours following initial diagnosis of partial ACKNOWLEDGEMENT hydatidiform mole order 4 mg cyproheptadine. Lancet 1990;335:1074–6 We thank Dr Manivasan Moodley MBChB buy discount cyproheptadine 4 mg on line, MMed discount cyproheptadine 4mg without prescription, FCOG for his comments and suggestions. The cancer registry in South cological malignancies, in both well- and under- Africa stopped collecting data in 1999 but the resourced parts of the world (Figure 11). Department of Health has recently started moves to The majority of women are diagnosed at an ad- recreate the South African Cancer Registry. In the vanced stage of disease due to the relative absence USA, there are approximately 21,550 new cases of of symptoms and signs during early stages of the ovarian cancer diagnosed per year, and more than disease. In addition, there are currently no cost- 14,600 women will die of the disease. It is the fifth effective screening tests with sufficient sensitivity most common cancer in women in the USA after or specificity for use in population screening to lung, breast, colon and uterus. In most underdeveloped countries, the most The difference in incidence between developed common causes of death in women are caused by countries and less-developed countries, could be communicable diseases such as HIV, tuberculosis, attributed to women having a shorter life expect- malaria and maternal mortality. Cancer is a less ancy in undeveloped countries [on average 45 years common cause of death but the incidence of cancer compared to 82 years (median age of patients with ovarian cancer is 56 years)]. In addition, women in poorer countries have some protection from life- style factors such as: • Late menarche • High parity. Survival Survival rates can be as high as 90% in early stages and decline in the late stages. Determinants of survival according to the SEER (Surveillance, Epi- demiology and End Results) database include race, Figure 1 Incidence of malignancies in women. Source: Global Cancer Statistics, 20022 Survival declines with age with 5-year survival rates 344 Ovarian Cancer of 77% in women aged <50 years compared with women with BRCA mutations tend to develop rates of 50% in women aged 50–69, and a reported ovarian cancer about 10 years earlier than non- 32% in women aged >70 years. There is also a higher risk of ovarian and endo- Borderline ovarian tumors as well as germ cell metrial cancer in women with the Lynch II syn- tumors are associated with a much better prognosis drome, which is also known as the hereditary while serous papillary cancers are associated with non-polyposis colorectal cancer (HNPCC) syn- poorer survival3,4. The mutations are autosomal dominant Varying inequalities in survival could exist be- and thus a complete family history is important to tween and within developing countries due to the document. General risk factors Risk factors General risk factors for ovarian cancer include low Genetic abnormalities: BRCA1 and BRCA2 and parity, infertility and endometriosis. Lynch syndrome About 10–14% of women with epithelial ovarian Protection against ovarian cancer cancer have a germ-line mutation in the BRCA1 The use of combined oral contraceptives (COC), or BRCA2 genes. BRCA1 is located on chromo- breastfeeding, tubal ligation and hysterectomy are some 17 and most genetic inherited ovarian cancers 5,6 protective. The lifetime risk of develop- ing ovarian cancer for women with BRCA1 muta- Staging for ovarian cancer according to the Inter- tion may be as high as 28–44% and for women national Federation of Gynecology and Obstetrics with the BRCA2 mutation around 27%. Table 1 Ovarian cancer staging by FIGO, 2009 Stage I Cancer limited to the ovaries IA Growth limited to one ovary, no ascites. No tumor on the external surfaces, capsule intact IB Growth limited to both ovaries, no ascites. No tumor on external surfaces, capsule intact IC Tumor either stage 1A or 1B, but with tumor on the surface of one or both ovaries, or with capsule ruptured, or with ascites containing malignant cells or with positive peritoneal washings Stage II Growth involving one or both ovaries with pelvic extension IIA Extension and/or metastases to the uterus and/or tubes IIB Extension to other pelvic tissue Stage III Tumor involving one or both ovaries with peritoneal implants outside the pelvis and/or positive retroperitoneal or inguinal node IIIA Tumor limited to the true pelvis with negative nodes but with histologically confirmed microscopic seeding of abdominal peritoneal surfaces IIIB Tumor of one or both ovaries with histologically confirmed implants of abdominal peritoneal surfaces, none exceeding 2 cm in diameter. Nodes negative IIIC Abdominal implants >2 cm in diameter and/or positive retroperitoneal or inguinal nodes IV Growth involving one or both ovaries with distant metastasis. If pleural effusion present, there must be positive cytological test results to allot a case to stage IV. Parenchymal liver metastases equals stage IV 345 GYNECOLOGY FOR LESS-RESOURCED LOCATIONS Classification/histological types CA-125 with ultrasound examination is dis- appointing even in high-risk groups (BRCA muta- Three main types of primary ovarian cancers exist. CA-125 is not diagnostic in premenopausal Epithelial cancers are the most common and women especially if the levels are low. High levels account for 80% of the cancers and are believed to of CA-125 tend to correlate with advanced stages. Ovarian Cancer Screening (UKCTOCS) was a The remainder (20%) are germ cell tumors, sex randomized controlled trial designed to assess the cord stromal tumors and cancers metastatic to the effect of screening on mortality, comparing ultra- ovaries. The most common is the serous papill- between the two strategies was not significant. Other types are endometrioid, Specificity was higher in the multimodal screening mucinous, clear cell, undifferentiated, Brenner, group resulting in fewer repeat tests and unneces- transitional cell and mixed histological types. It must be said, that the Borderline epithelial tumors or tumors of low ultrasound screening was performed by experi- malignant potential tend to remain confined to enced sonographers, and similar results may not be the ovary for long periods of time, occur in reproducible in less-developed countries. SIGNS AND SYMPTOMS Another entity that is recognized is primary Many patients with early-stage ovarian cancer do peritoneal carcinoma which simulates ovarian not have signs or symptoms and the abdominal cancer clinically, although there is usually exten- mass is diagnosed by coincidence. Patients with sive intra-abdominal disease associated with nor- advanced disease often present with vague gastro- mal sized ovaries or with tumor only on the intestinal complaints, weight loss, micturition and ovary surface. CA-125 is the most common defecation changes, abdominal distention, progres- tumor marker of epithelial ovarian cancers.

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Relative risk: The ratio of risks in two groups; same as a risk ratio cheap cyproheptadine 4 mg visa. Retrospective study: A study in which the outcomes have occurred prior to study entry purchase cyproheptadine 4 mg overnight delivery. Risk: A way of expressing the chance that something will happen buy cyproheptadine 4mg lowest price. It is a measure of the association between exposure to something and what happens (the outcome). Risk is the same as probability, but it usually is used to describe the probability of an adverse event. It is the rate of events (such as breast cancer) in the total population of people who could have the event (such as women of a certain age). Risk difference: The difference in size of risk between two groups. In intervention studies, it is the ratio of the risk in the intervention group to the risk in the control group. A risk ratio of 1 indicates no difference between comparison groups. For undesirable outcomes, a risk ratio that is <1 indicates that the intervention was effective in reducing the risk of that outcome. Second-generation antidepressants 188 of 190 Final Update 5 Report Drug Effectiveness Review Project Run-in period: Run in period: A period before randomization when participants are monitored but receive no treatment (or they sometimes all receive one of the study treatments, possibly in a blind fashion). The data from this stage of a trial are only occasionally of value but can serve a valuable role in screening out ineligible or non-compliant participants, in ensuring that participants are in a stable condition, and in providing baseline observations. A run-in period is sometimes called a washout period if treatments that participants were using before entering the trial are discontinued. This term (or the term ‘‘safe’’) should not be used when evidence on harms is simply absent or is insufficient. Sample size: The number of people included in a study. In research reports, sample size is usually expressed as "n. Larger sample sizes also increase the chance that rare events (such as adverse effects of drugs) will be detected. Sensitivity analysis: An analysis used to determine how sensitive the results of a study or systematic review are to changes in how it was done. Sensitivity analyses are used to assess how robust the results are to uncertain decisions or assumptions about the data and the methods that were used. Side effect: Any unintended effect of an intervention. Side effects are most commonly associated with pharmaceutical products, in which case they are related to the pharmacological properties of the drug at doses normally used for therapeutic purposes in humans. Standard deviation (SD): A measure of the spread or dispersion of a set of observations, calculated as the average difference from the mean value in the sample. Standard error (SE): A measure of the variation in the sample statistic over all possible samples of the same size. The standard error decreases as the sample size increases. Standard treatment: The treatment or procedure that is most commonly used to treat a disease or condition. In clinical trials, new or experimental treatments sometimes are compared to standard treatments to measure whether the new treatment is better. Statistically significant: A result that is unlikely to have happened by chance. Study: A research process in which information is recorded for a group of people. The data are used to answer questions about a health care problem. Study population: The group of people participating in a clinical research study. The study population often includes people with a particular problem or disease. It may also include people who have no known diseases. Subgroup analysis: An analysis in which an intervention is evaluated in a defined subset of the participants in a trial, such as all females or adults older than 65 years. Superiority trial: A trial designed to test whether one intervention is superior to another. Surrogate outcome: Outcome measures that are not of direct practical importance but are believed to reflect outcomes that are important; for example, blood pressure is not directly important to patients but it is often used as an outcome in clinical trials because it is a risk factor for stroke and heart attacks. Surrogate endpoints are often physiological or biochemical markers that can be relatively quickly and easily measured, and that are taken as being predictive of important clinical outcomes. They are often used when observation of clinical outcomes requires long follow-up.

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Only 40 percent of trials characterized trial populations by race and in those buy cyproheptadine 4 mg overnight delivery, the majority of patients were white (81 generic 4 mg cyproheptadine amex. Eligibility criteria differed across trials with regard to symptom severity purchase cyproheptadine 4mg line, verification, and history and this is a potential source of heterogeneity across patient populations (Table 4). Trials also differed in which, if any, concomitant treatments were allowed and whether use of these was recorded. NCS Page 15 of 71 Final Report Update 1 Drug Effectiveness Review Project Table 4. Seasonal allergic rhinitis trial characteristics Trial Eligibility criteria Allowed concomitant treatments Symptom severity 24-month Positive skin prick scores history test Antihistamines Immunotherapy Kaiser, 2004 TNSS • 42 ¥ ¥ Gross, 2002 TNSS • 42 ¥ ¥ ¥ Ratner, 1992 INSS • 200 ¥ ¥ ¥ a Graft, 1996 TNSS ” 2 ¥ ¥ ¥ McArthur, 1994 ¥ Langrick, 1984 ¥ Ratner, 1996 TSS = 2-7 ¥ ¥ ¥ ¥ Welsh, 1987 ¥ ¥ ¥ ¥ Stern, 1997 ¥ ¥ ¥ Greenbaum, 1988 ¥ ¥ ¥ TSS • 6; congestion • 2 Hebert, 1996 + one other ¥ ¥ ¥ ¥ symptom (INSS) Lumry, 2003 RIS • 24 ¥ ¥ ¥ ¥ Small, 1997 RIS • 24 ¥ ¥ ¥ LaForce, 1994 INSS • 200 ¥ ¥ Bronsky, 1987 EENT • 8 ¥ ¥ a Prophylaxis trial TNSS=Total Nasal Symptom Score; INSS=Individual Nasal Symptom Score; TSS=Total Symptom Score; RIS=Rhinitis Index Score; EENT=Eye, Ear, Nose & Throat Noseasonalallergicrhinitistrial was rated good quality. The only trial rated poor, Greenbaum 1988, suffered from multiple flaws including inadequately described randomization and allocation concealment methods, a complete lack of inclusion criteria and reporting of baseline demographics, and excluded a number of patients 24 from the outcome assessment. The majority of the trials were sponsored by the pharmaceutical 20 24, 26, 29 industry. Sponsor information was not reported in 1 trial and 3 trials did not acknowledge receiving funding but had authors employed by pharmaceutical companies. No head-to-head trials in seasonal allergic rhinitis patients of the new drugs included in this update, ciclesonide and fluticasone furoate were identified through searches. One unpublished abstract of a head-to-head trial of fluticasone furoate 110 mcg/day compared with fluticasone 200 mcg/day provided by the manufacturer of fluticasone furoate suggested that 30 fluticasone furoate was non-inferior to fluticasone in terms of efficacy and safety. A published, peer reviewed report of these findings was not identified through literature searches, therefore these results should be considered inconclusive. Results oftrials oftreatment in adults with seasonal allergic rhinitis 1. Direct comparisons Similar proportions of patients experienced significant global improvements in rhinitis symptoms after 3 to 7 weeks of treatment based on physician assessment in head-to-head trials of nasal corticosteroids (Table 5). Physician assessment of global improvement was the most commonly reported outcome, was defined differently across trials, and was generally based on NCS Page 16 of 71 Final Report Update 1 Drug Effectiveness Review Project patient diary ratings (0=none; 3=severe) of nasal symptom severity of rhinorrhea, stuffiness/congestion, nasal itching, and sneezing. The lowest rates of patient improvement were observed in a 7-week trial of flunisolide 200 mcg 20 compared with beclomethasone 400 mcg (29% compared with 34%, NS). Reasons for why the rates in this trial differed from the others may have been that the mean age was noticeably higher at 66. Rates of patient improvement were also quite low in the only trial to 26 prohibit concomitant usage of both antihistamines and immunotherapy. The third lowest patient improvement rates came from the trial with the shortest treatment period of only 2 weeks. Patient improvement rates may have been lower in this trial because the treatments may not have 16 reached their maximum effect within that time. Only 2 trials pre-specified a primary outcome measure, which was the mean change in 14, 15 composite rhinitis symptom score. Measurement of change in composite symptom scores was also the second most commonly reported outcome; however, these were defined differently across trials (Table 5). There were no significant differences between any 2 nasal corticosteroids 13-15, 17, 19, 21-23, 29 in any of the trials that reported these outcomes for the treatment periods overall. Therewasadifferencein1trialwhenprimary outcome scores were analyzed only on 3 14 days when the pollen count was greater than 10 grains/m. Results of this trial demonstrated that budesonide 256 mcg per day was superior in reducing combined symptom scores, as well as the individual scores for sneezing and runny nose when compared to fluticasone 200 mcg and 14 budesonide 128 mcg daily. Rhinitis symptom assessment outcomes in adults with seasonal allergic rhinitis Study Age Physician-rated global Sample size % evaluation of % Change in total Trial duration female Treatment A Treatment B improvement (% pts) symptom score McArthur, 1994 27 Noticeably, very or total Budesonide Beclomethasone N=77 years effective: 85% compared NR 200 mcg 200 mcg 3 weeks 51% with 82%, NS Langrick, 1984 66. RQLQ items are organized into 7 dimensions (activities, emotions, eye symptoms, nasal symptoms, non-hay fever problems, practical problems, and sleep) and each are rated using a 7-point Likert Scale (0 to 6; lower scores indicate better QOL). Triamcinolone AQ 220 mcg was associated with similar mean 19 reductions in RQLQ total score after 3 weeks relative to beclomethasone and fluticasone (Table 23, 27 6). NCS Page 18 of 71 Final Report Update 1 Drug Effectiveness Review Project Table 6. Mean change in RQLQ total score Study Sample size Age Trial duration % female Treatments Point reductions Lumry, 2003 Triamcinolone AQ 220 mcg 37 years N=147 compared with beclomethasone 336 -1. Out of those 9 trials, only 5 reported the raw data for comparison of numerical reduction in symptom severity and no differences between nasal corticosteroids were 13, 14, 17, 19, 26 reported. When the reduction in eye symptoms is compared to the reduction for other symptoms of seasonal allergic rhinitis in these head-to-head trials it tends to be less dramatic. Indirect comparisons As no published head-to-head trials were identified through searches, the evidence on the effectiveness of ciclesonide and fluticasone furoate in seasonal allergic rhinitis patients is limited to placebo-controlled trials. Two trials comparing ciclesonide 200 µg/day to placebo had similar patient populations 31, 32 and primary outcomes (Table 7 and Evidence Table 1a).

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Q uality assessm entofrandom iz ed controlled trials ofnewerdrugs forinsom nia Post- A uth or cheap cyproheptadine 4 mg online, A dh erence L oss to fu L oss to fu ITT randomiz atio Q uality year reported C ontamination reported? A nsoms order 4mg cyproheptadine with visa, N o N o Y es 54 enrolled buy 4 mg cyproheptadine otc, N o Y es F air N ot 1991 27 z opiclone reported and 25 lormetaz epa m evaluable, butnumbers randomiz ed notreported. Insomnia 250 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 8a. Q uality assessm entofrandom iz ed controlled trials ofnewerdrugs forinsom nia Post- A uth or, A dh erence L oss to fu L oss to fu ITT randomiz atio Q uality year reported C ontamination reported? Bergener, N o N o Y es 16 of42 U nable to N o F air N ot 1989 patients determine reported (38% ) dropped out, butnot differential(8 ineach group)and information provided on reasons for dropout. Boz in- N o N o N o U nable to Y es F air M ay and Juracic, determine Becker 1998 and R h one- Poulenc Sante C h audoir, N o N o Y es H igh (16. Q uality assessm entofrandom iz ed controlled trials ofnewerdrugs forinsom nia Post- A uth or, A dh erence L oss to fu L oss to fu ITT randomiz atio Q uality year reported C ontamination reported? Q uality assessm entofrandom iz ed controlled trials ofnewerdrugs forinsom nia Post- A uth or, A dh erence L oss to fu L oss to fu ITT randomiz atio Q uality year reported C ontamination reported? H edner, N o N o N R N o N R F air 2000 (422/437 analyz ed) Insomnia 253 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 8a. Q uality assessm entofrandom iz ed controlled trials ofnewerdrugs forinsom nia Post- A uth or, A dh erence L oss to fu L oss to fu ITT randomiz atio Q uality year reported C ontamination reported? Insomnia 254 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 8a. Q uality assessm entofrandom iz ed controlled trials ofnewerdrugs forinsom nia Post- A uth or, A dh erence L oss to fu L oss to fu ITT randomiz atio Q uality year reported C ontamination reported? Q uality assessm entofrandom iz ed controlled trials ofnewerdrugs forinsom nia Post- A uth or, A dh erence L oss to fu L oss to fu ITT randomiz atio Q uality year reported C ontamination reported? Q uality assessm entofrandom iz ed controlled trials ofnewerdrugs forinsom nia Post- A uth or, A dh erence L oss to fu L oss to fu ITT randomiz atio Q uality year reported C ontamination reported? Q uality assessm entofrandom iz ed controlled trials ofnewerdrugs forinsom nia Post- A uth or, A dh erence L oss to fu L oss to fu ITT randomiz atio Q uality year reported C ontamination reported? Q uality assessm entofrandom iz ed controlled trials ofnewerdrugs forinsom nia Post- A uth or, A dh erence L oss to fu L oss to fu ITT randomiz atio Q uality year reported C ontamination reported? W alsh , N o N o N o-unclear N o (48/54 Y es Poor 2000a ifdifferential analyz ed) Insomnia 259 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 8a. Q uality assessm entofrandom iz ed controlled trials ofnewerdrugs forinsom nia Post- A uth or, A dh erence L oss to fu L oss to fu ITT randomiz atio Q uality year reported C ontamination reported? Ph armace 2002 3% placebo, uticals 30% z olpidem W are, N o N o N o N o N o F air L orex 1997 Ph armace uticals W h eatley, N o N o N o U nable to U nable to F air N ot 1985 determine determine reported Z ammit, N o N o N o N o N o F air Sepracor 2004 (303/308 atnigh t1; 293/308 at 1 month ) Z ammit, 2007 Insomnia 260 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 8b. Q uality assessm entofrandom iz ed controlled trials (new forU pdate #2) A llocation R andomiz ation concealment G roups Inclusion Exclusion O utcome C are meth od meth od similarat criteria criteria assessors provider Patients A ttrition A uth or Y ear described? Berry 2006 M eth od not M eth od not Y es Y es N R N R N R Y es described described F ava 2006 M eth od not M eth od not Y es Y es Y es U nclear, U nclear, U nclear, described described reported as reported reported double blind as double as double blind blind K ryger 2007 M eth od not M eth od not N R N otreported Y es Y es U nclear, U nclear, Y es Y es described described by orderof reported as reported randomiz ati double blind as double on blind K rystal 2008 M eth od not M eth od not Y es Y es Y es U nclear, U nclear, Y es Y es 2008 described described reported as reported double blind as double blind M cC all 2006 M eth od not M eth od not Y es Y es Y es Y es U nclear, U nclear, Y es described described reported reported as double as double blind blind R osenber 2007 M eth od not M eth od not N R N otreported Y es Y es U nclear, U nclear, U nclear, Y es g described described by orderof reported as reported reported randomiz ati double blind as double as double on blind blind R oth 2007 2007 M eth od not M eth od not Y es Y es Y es U nclear, U nclear, U nclear, Y es described described reported as reported reported double blind as double as double blind blind Insomnia 261 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 8b. Q uality assessm entofrandom iz ed controlled trials (new forU pdate #2) A llocation R andomiz ation concealment G roups Inclusion Exclusion O utcome C are meth od meth od similarat criteria criteria assessors provider Patients A ttrition A uth or Y ear described? Soares 2006 M eth od not M eth od not Y es Y es Y es U nclear, U nclear, U nclear, Y es described described reported as reported reported double blind as double as double blind blind W alsh 2008 M eth od not Y es N o N umberof Y es Y es Y es U nclear, Y es Y es described awakenings reported and sleep as double quality blind h igh erin placebo group (different directions) W alsh 2007 M eth od not M eth od not Y es Y es Y es Y es Y es Y es Y es (esz opiclo described described ne) Insomnia 262 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 8b. Q uality assessm entofrandom iz ed controlled trials (new forU pdate #2) A llocation R andomiz ation concealment G roups Inclusion Exclusion O utcome C are meth od meth od similarat criteria criteria assessors provider Patients A ttrition A uth or Y ear described? Z ammit 2007 M eth od not Y es N o Differences Y es Y es Y es Y es Y es (ramelteon described inweigh t ) and sexat baseline Insomnia 263 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 8b. Q uality assessm entofrandom iz ed controlled trials (new forU pdate #2) H andling of Post- carryover randomiz a effects (for L oss to fu tion W ith drawalrate crossover differential ITT exclusions differentialor studies A uth or orh igh? C omment only) F unding Berry N o U nable to N o N o determine F ava Y es 50/545 Y es 543/545 Y es 40 for Y es 172/545 Sepracor (9. Q uality assessm entofrandom iz ed controlled trials (new forU pdate #2) H andling of Post- carryover randomiz a effects (for L oss to fu tion W ith drawalrate crossover differential ITT exclusions differentialor studies A uth or orh igh? C omment only) F unding Soares N o 4/410 (1% ) Y es Y es 13 for N o 51/410 Sepracor protocol (12. Q uality assessm entofrandom iz ed controlled trials (new forU pdate #2) H andling of Post- carryover randomiz a effects (for L oss to fu tion W ith drawalrate crossover differential ITT exclusions differentialor studies A uth or orh igh? C omment only) F unding Z ammit N o 1/405 N o Y es 6 for N o 34/405 Takeda (ramelteon protocol with drew ) deviation, (8. O bservationalstudies A uth or N Drugs (m ean Durationof Eligibility C riteria Y ear dose);durationof treatm ent C ountry treatm ent A llain,1991 20,513 Z opiclone 7. Insomnia 267 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 9. O bservationalstudies A uth or O th erpopulation Design Datasources Tim e period A dverse events Y ear ch aracteristics of assessm ent C ountry assessm ent A llain,1991 62. O bservationalstudies A uth or R esults F unding Y ear C ountry A llain,1991 N europsych iatricadverse events,no. O bservationalstudies A uth or N Drugs (m ean Durationof Eligibility C riteria Y ear dose);durationof treatm ent C ountry treatm ent A ncoli- 260 Z aleplon5 mg, 1 year Primary insomnia defined by Israel, increased to 10 DSM -IV criteria.

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