Iraqi J Pharm Sci, Vol.26(2) 2017 Patients with diabetes mellitus, hypertension or both diseases 29 Assessing Quality of Life Among Patients with Diabetes Mellitus, Hypertension or Both Diseases in Al-Najaf Province /Iraq Ali S. Al-Ibrahimy*,1 and Haydar F.Al-Tukmagi** * Department of Clinical Pharmacy, College of Pharmacy, University of Kufa, AL-Najaf , Iraq. ** Department of Clinical Pharmacy, College of Pharmacy, University of Baghdad, Baghdad Iraq. Abstract With growing prevalence, diabetes mellitus will be possibly the most principal cause for morbidity and mortality in next years. The predominance of diabetes mellitus has been increased over the last decades, where the occurrence of disease is anticipated to increase to 592 million at 2035. Essential hypertension is chronic non-communicable disease which considered the major risk factor for many diseases. The world health organization estimates that the hypertensive patients will reach 1 billion or more at year 2025. The purpose of insertion of quality of life as indicator for health outcome is due to sensitivity of this measure for patients’ evaluations of their health status after taken treatment and its health outcome. This study is a cross-sectional survey. The total number of participants in this study was 775 individuals which divided into four groups: healthy control group, patients with diabetes mellitus only, hypertension only and patients with both diabetes mellitus and hypertension. The questionnaire used to assess quality of life is Arabic version of (WHOQOL- BRIEF). The mean scores of the four domains of QOL instrument for diabetic, hypertensive and diabetic hypertensive patients were statistically significant lower than corresponding domains of control group. In conclusion, one chronic disease affects quality of life and combination of two chronic diseases affect quality of life to greater extent. Keywords: Diabetes mellitus, Hypertension, Quality of life, WHOQOL- BRIEF. مرضى داء السكري من النوع الثاني تقييم نوعية الحياة الصحية لدى العراق -الدم في محافظة النجف األشرف و إرتفاع ضغط ا /و **جي هو حيدر فخري التكم 1*,االبراهيميعلي شالش فرع الصيدلة السريرية ، كلية الصيدلة ، جامعة الكوفه ، النجف ، العراق .* الصيدلة السريرية ، كلية الصيدلة ، جامعة بغداد ، بغداد ، العراق . عفر ** لخالصة ا المتزايد، فإن مرض السكري ربما يكون السبب الرئيسي لالمراض والوفيات في السنوات المقبلة. وساد هذا المرض مع االنتشار أما ارتفاع 5302مليون في عام 295المصابين بهذا المرض إلى بصورة كبيرة في العقود األخيرة ، حيث من المتوقع أن يزداد عدد تقدر منظمة الصحة حيث ة غير المعدية التي تعتبر عامل الخطر الرئيسي لكثير من األمراضمن األمراض المزمن ضغط الدم األساسي هو يرجع الغرض من إدراج دراسة نمط الحياة كمؤشر .5352مرضى ارتفاع ضغط الدم سيصل إلى مليار أو أكثر في عام عدد العالمية أن حيث ان هذه دراسة شاملة مستعرضة المرضى لحالتهم الصحية بعد اخذ العالجللنتائج الصحية إلى قدرة هذا العامل على الكشف عن تقييم ومجموعة مرضى التي تشمل المجموعة الضابطة موعاتشخص مقسمين على اربعة مج 772لمرضى الضغط والسكري اجريت على ستبيان منضمة الصحة العالمية حول م النسخة العربية الموجزة الااستخد تم الضغط و مجموعة السكري ومجموعة الضغط والسكري معا. قد تأثرت بدرجة يعتد بها ظهرت هذه الدراسة ان معدل الدرجات للمجاالت االربعة )البدني والنفسي واالحتماعي والبيئي (أنمط الحياة. ان المرض المزمن ب .وبذلك يمكن االستنتاج شخاص االصحاء في المجموعة الضابطةاحصائيا مقارنة مع درجات هذه المجاالت عند األ ثران ؤثر على كافة مجاالت الحياة التي قيست في هذا االستبيان بدرحة معتد بها احصائيا اما اذا اجتمع مرضان مزمنان فانهما يؤالواحد ي بدرجة اكبر. .ة العالميةمرض السكري ، ارتفاع ضغط الدم ، نوعية الحياة ، النسخة الموجزة الستبان منظمة الصح الكلمات المفتاحية : Introduction Diabetes mellitus (DM) is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both (1). The long- term effects of these metabolic irregularities lead to appearance of chronic complications of diabetes mellitus (2). These complications can affect many organ systems. The diabetic complications are divided into macrovascular and microvascular complications (3). The predominance of DM has been increased over the last decades ,where the occurrence of disease is anticipated to increase to 592 million at 2035 (4). According to World Health Organization (WHO) eastern Mediterranean region, the prevalence of DM in Iraq was (668,000) by 2000 and is expected to increase to (2009, 000) by 2030. 1Corresponding author E-mail: alipharm1989@yahoo.com Received:29 /7/2017 Accepted: 21/9/2017 mailto:alipharm1989@yahoo.com Iraqi J Pharm Sci, Vol.26(2) 2017 Patients with diabetes mellitus, hypertension or both diseases 30 There are many subtypes of DM present, but the type-1 diabetes mellitus (T1DM) and type-2 diabetes mellitus (T2DM) are the most common form of the disease and account for approximately 95 ٪ of overall cases (5). The T1DM takes 5-10٪of the cases; while, T2DM accounts for ~90% of cases (6). Hypertension is chronic non-communicable disease in which there is persistent elevation of systolic and/or diastolic blood pressure of ≥ 140/90 mm Hg; it may be considered the major risk factor for cardiovascular, cerebrovascular and renovascular diseases (7-9). In 2008 the prevalence of hypertension worldwide is about 40% in adults of 25 years and above (10). The WHO estimate that the hypertensive patients will reach 1 billion or more at year 2025 (11). The World Health Organization defines quality of life as “an individual's perception of their position in life in the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards, and concerns (12). The purpose of insertion of quality of life (QOL) as indicator for health outcome is attributed to the sensitivity of this measure for the evaluation of patients health status after taken treatment and its health outcome; where, the evaluation of quality of life is important because this evaluation can determine the aspects that are significant for quality of life of patients (13, 14) because the ultimate goal for treatment of chronic non- curable diseases like diabetes mellitus and hypertension is to improve the quality of life of such patients (15). QOL's value is important for knowing what is significant to the individuals’ QOL (13, 14) due to the principal goal for non- curative disease is to improve QOL (15). Diabetes mellitus (DM) as indicated by many studies to be independently associated with reduced levels of quality of life as evidenced by negative relationship between DM and many aspects of life like physical, mental, and social, financial aspects of individuals (16-18). The diabetic patients require controlling the symptoms of disease and adhering to complex regimens of treatment (19). Thus, the impact of diabetes mellitus on quality of life can be analyzed into two interdependent aspects: the consequences attributed to the disease-related stressors and the burden imposed by the treatment demanding thus both the disease-related stressors and the burden if treatment of this disease may increase the risk making person more susceptible to the poor QOL (19). Several investigators have indicated that hypertension can seriously affect QOL and patients well-being; where, it was shown that the known hypertensive patients have poorer QOL because the diagnosis of hypertension increases the sensitivity of patients toward bodily symptoms and make an otherwise “healthy” person ill (20). Method This study is a cross-sectional survey conducted to determine the impact of DM and hypertension on QOL in Iraqi patients in AL- Najaf AL-Ashraf province. The total number of participants in this study was 775 individuals which divided into four groups including healthy control group (190 persons), type-2 diabetic patients (194 patients), hypertensive patients (195 patients) and patients with both T2DM and hypertension (196 patients). The study was approved by Scientific Committee of the College of Pharmacy–Baghdad University. The participants in this study including known T2DM and hypertensive patients who attended at community pharmacies in urban and rural areas. After explaining the aims of the study to patients, the agreement of participation was obtained and the questionnaire provided to eligible individual. The identification of diabetic or hypertensive patients ensued after asking the patients to answer the question “do you have any of the following diseases diagnosed by doctor: DM, hypertension or DM plus hypertension“. The inclusion criteria involve all patients with T2DM, hypertension or both diseases who visited community pharmacy. The diabetic- and hypertensive- patients should be treated at least six month before enrollment in the study. The exclusion criteria include pregnant- or breast- feeding women, patients with any other co- morbidity not related to disease and patients who cannot complete the QOL measures because of psychiatric or cognitive impairments that affect memory or judgment. The questionnaire was provided to all patients to be self-reported with exception of illiterate patients that were interviewed by trained community pharmacists who also report the treatment that has been taken by the patients. Furthermore, such questionnaire contain organized questions such as - demographic information (gender, age, education level, marital status, occupation, residence), - duration of disease, -family history, and - smoking status. The questionnaire for the assessment of QOL of persons is the Arabic version of World Health Organization QOL– Short Version questionnaire (WHOQOL-BRIEF) was utilized (21, 22). This questionnaire comprised of four domains each one measure specific aspect of life namely physical, psychological, Iraqi J Pharm Sci, Vol.26(2) 2017 Patients with diabetes mellitus, hypertension or both diseases 31 social and environmental domains. In addition, it also contains two other questions that ask about the general health and general quality of life. Consequently this instrument has 26 questions. Each item rated according to five points likert scale with arrangement in positive direction thus, high score refer to better QOL; while, low score mean lower quality of life. The total score of domain was calculated by summation of scores of items that included in this domain after reverse the direction of three items in this questionnaire which are questions (3, 4 and 26). Then calculate the mean of scores for each domain and use this mean to convert the domain score to (4-20) range by multiplying the mean by 4. Then transformation to (0-100) range occur by use this formula ((score – 4) * 100/16). The sum of scores of four domains produces overall value of quality of life. The duration of study continued from November (2016) to March (2017). The statistical analysis performed by using IBM SPSS Statistics version 23. The categorical variables represented by descriptive statistics like percentages and frequencies. The Continuous variables were presented as (Means ± SD). The internal reliability of questionnaire is evaluated by Cronbach's alpha while Student’s t- test , Mann-Whitney Test and Kruskal Wallis Test are used to compare between means of unpaired groups. When more than 20% of data was missed from assessment, the assessment was discarded. When the score of single item was missed the mean of other items was used to substitute the missing value. When two items were coded missing , the domain score was not computed with the exception of domain 3, where the domain should only be calculated if < 1 item is missing) ( 23). Results The internal reliability of questionnaire based on Cronbach's alpha value is (0.88) and for domains is ranged from (0.65) for social domain to (0.85) for physical domain indicates good internal consistency. Also, Pearson correlation coefficient show significant correlation between each item and the domain that comprise it. The mean age diabetic, hypertensive, DM plus hypertension patients and control group include 51.18 ± 10.220, 51.90 ± 10.928, 56.03 ± 8.878 and 50.05 ± 9.20 years respectively. The male participants for all groups are greater than female participants (Table 1). Table (1): Age of the study groups (Mean ±SD) study groups Age (Mean ±SD years) Range ( years) Diabetic patients 51.18 ± 10.220 32-78 Hypertensive patients 51.90 ± 10.928 25-84 Diabetic hypertensive patients 56.03 ± 8.878 37-80 Control group 50.05 ± 9.20 33- 67 Table(2): Distribution of participants according to rural or urban area Study groups Number of participants in rural area ( AL- ABASIA) (7 community pharmacy) Number of participants in urban area (30 community pharmacy) Diabetic patients 29 ( 14.9) 165 (85.1) Hypertensive patients 37 ( 19) 158 (81) Diabetic hypertensive patients 18 (9.2) 178 (90.8) Control group 22 (11.6) 168(88.4) The majority of type 2 diabetic patients (35.6 %) have secondary educational level; while, the illiterate patients take highest percent (29.7 %) among hypertensive patients but majority of (38.8 %) hypertensive diabetic patients have primary school educational level and finally the most of control group individuals (44 %) have college educational level (Table 3). The majority of participants of all groups were married (Table 3). The mean scores of the four domains of QOL instrument for diabetic patients were statistically significant lower (P<0.001) than corresponding domains of control group (Table 5) also the mean scores of the four domains of QOL instrument for hypertensive patients were statistically significant lower (P<0.001) than corresponding domains of control group (Table 6 ). The mean scores of the four domains of QOL instrument for diabetic hypertensive patients were statistically Iraqi J Pharm Sci, Vol.26(2) 2017 Patients with diabetes mellitus, hypertension or both diseases 32 significant lower (P<0.001) than corresponding domains of control group (Table 7). The overall QOL scores (OQOL) for all patients group were significantly lower (P<0.001) than that of control group (Table 8). The comparison of mean of overall quality of life values between patients group showed that the effect of T2DM and hypertension were non-significantly different (P>0.05); while the presence of T2DM and hypertension together reduce the value of mean overall quality of life (OQOL) significantly (P<0.05) when compared with T2DM alone and hypertension alone (Table 9 ). Figures (1, 2, 3, and 4) illustrated the response to first two questions about general health and QOL. Table (3): Demographic characteristics of study participants Variable Diabetic Hypertensive Diabetic hypertensive Control p- value Gender Male 108(55.7) 101 (51.8) 101 (51.5) 98 (51.6) 0.813 Female 86 (44.3) 94 (48.2) 95 (48.5) 92 (48.4) Education level illiterate 42 (21.6) 58 (29.7) 48 (24.5) 11 (5.8) 0.001 primary school 63 (32.5) 53 (27.2) 76 (38.8) 19 (10.0) secondary school 69 (35.6) 51 (26.2) 55 (28.1) 75 (39.5) collage 20 (10.3) 33 (16.9) 17 (8.7) 85 (44.7) Marital status single 4 (2.1) 6 (3.1) 4 (2.0) 10 (5.3) 0.165 married 172 (88.7) 153 (78.5) 162 (82.7) 155 (81.6) Widowed 13 (13.7) 31 (15.9) 26 (13.3) 20 (10.5) Divorced 5 (2.6) 5 (2.6) 4 (2.0 ) 5 (2.6) Duration of Disease Less than 1 year 11 (5.7) 10 (5.1) 5 (2.6)* 8 (4.1)** --- --- 0.001 1- 5 year 72 (37) 91 (46.7) 45(22.9)* 75(38.3)** --- --- 6 – 10 years 46 (24) 54 (27.7) 58(29.6)* 54(27.5)** --- --- More than 10 years 65 (33.3) 40 (20.5) 88(44.9)* 59(30.1)** --- --- Residence Urban 165 (85.1) 158 (81) 178 (90.8) 168(88.4) 0.030 Rural 29 ( 14.9) 37 ( 19) 18 (9.2) 22 (11.6) Occupation Employed 43 (22.2) 48 (24.6) 37 (18.9) 72 (37.9) 0.001 Non employed 151 (77.8) 147 (75.4) 159 (81.1) 118 (62.1) Iraqi J Pharm Sci, Vol.26(2) 2017 Patients with diabetes mellitus, hypertension or both diseases 33 Continued table (3) *mean duration of diabetes mellitus , ** mean duration of hypertension Table (4): Number and type (s) of drug(s) taken by diabetic patients Drug number Percent % Drug class(s) Percent % One drug 58 (29.8) Sulfonylurea 11 (18.9) Biguanide 16 (28.3) Insulin 31 ( 52.8) Two drugs 123 (63.5) Insulin + biguanide 62 (50.4) Sulfonylurea + biguanide 58 ( 47.2) DPP4I+ biguanide 2 ( 1.6) Insulin +sulfonylurea 1 (0.8) Three drugs 13 (6.7) Insulin+sulfonylurea+biguanide 7 (53.8) DPP4I+sulfonylurea+biguanide 6 (46.2) DPP4I:dipeptidyl peptidase -4 inhibitor Variable Diabetic Hypertensive Diabetic hypertensive Control p-value Family history Yes 128 (66) 149 (76.4) 132 (67.3) ------ 0.051 No 66 (34) 46 (23.6) 64 (32.7) ------ Smoking habit Smoker 39 (20.1) 40 (20.5) 46 (23.5) 44(23.2) 0.752 Non smoker 155(79.0) 155 (79.5) 150 (76.5) 146 (76.8) Treatment Diet only 3 (1.6) 9 ( 4.6) 1 (0.5) ------ 0.001 One drug 58 (29.8) 109 (55.9) ------ ------ Two drugs 123(63.5) 58 (29.8) 43 (21.9) ------ Three drugs 13 (6.7) 16 (8.2) 103 (52.5) ------ Four drugs ------ 2 (1.0) 42 (21.5) ------ Five drugs ------ 1 (0.5) 5 (2.6) ------ Six drugs ------ ------ 2 (1.0) ------ Iraqi J Pharm Sci, Vol.26(2) 2017 Patients with diabetes mellitus, hypertension or both diseases 34 Figure (1) :The proportion of responses of diabetic group for first two items of WHOQOL-BREF about the perception of general health and quality of life. WHOQOL-BREF = World Health Organization Quality of Life- Brief questionnaire . Figure (2) :The proportion of responses of hypertensive group for first two items of WHOQOL- BREF about the perception of general health and quality of life. WHOQOL-BREF = World Health Organization Quality of Life- Brief questionnaire Iraqi J Pharm Sci, Vol.26(2) 2017 Patients with diabetes mellitus, hypertension or both diseases 35 Figure (3) :The proportion of responses of diabetic hypertensive group for first two items of WHOQOL-BREF about the perception of general health and quality of life. WHOQOL-BREF = WorldHealth Organization Quality of Life- Brief questionnaire Figure (4) :The proportion of responses of control group for first two items of WHOQOL-BREF about the perception of general health and quality of life. WHOQOL-BREF = World Health Organization Quality of Life- Brief questionnaire. Iraqi J Pharm Sci, Vol.26(2) 2017 Patients with diabetes mellitus, hypertension or both diseases 36 Table( 5): Comparison of QOL domain scores between DM patients and control group Scale Domain Diabetic group Control group p- value 4-20 Physical 11.32 ± 3.59 14.50 ± 1.86 < 0.001 Psychological 12.29 ± 2.60 14.27 ± 1.58 < 0.001 social 12.78 ± 2.77 14.73 ± 2.05 < 0.001 Environmental 11.61 ± 2.31 13.44 ± 1.41 < 0.001 0-100 Physical 45.80 ± 22.45 65.68 ± 11.60 < 0.001 Psychological 51.82 ± 16.28 64.18 ± 9.93 < 0.001 Social 54.89 ± 17.31 67.10 ± 12.85 < 0.001 Environmental 47.59 ± 14.47 59.01 ± 8.86 < 0.001 QOL: quality of life , DM : diabetes mellitus Table (6): Comparison of QOL domain scores between hypertensive patients and control group Scale Domain Hypertensive group Control group p- value 4-20 Physical 11.52 ± 2.69 14.50 ± 1.86 < 0.001 Psychological 12.76 ± 2.38 14.27 ± 1.58 < 0.001 social 13.43 ± 3.04 14.73 ± 2.05 < 0.001 Environmental 11.89 ± 2.01 13.44 ± 1.41 < 0.001 0-100 Physical 47.03 ± 16.81 65.68 ± 11.60 < 0.001 Psychological 54.78 ± 14.91 64.18 ± 9.93 < 0.001 Social 58.97 ± 19.01 67.10 ± 12.85 < 0.001 Environmental 49.34 ± 12.58 59.01 ± 8.86 < 0.001 QOL: quality of life Iraqi J Pharm Sci, Vol.26(2) 2017 Patients with diabetes mellitus, hypertension or both diseases 37 Table (7): Comparison of QOL domain scores between diabetic hypertensive patients and control group. Scale Domain DM plus hypertension Control group p- value 4-20 Physical 10.20 ± 3.32 14.50 ± 1.86 < 0.001 Psychological 11.74 ± 2.87 14.27 ± 1.58 < 0.001 social 12.41 ± 3.01 14.73 ± 2.05 < 0.001 Environmental 11.04 ± 2.24 13.44 ± 1.41 < 0.001 0-100 Physical 38.77 ± 20.77 65.68 ± 11.60 < 0.001 Psychological 48.38 ± 17.94 64.18 ± 9.93 < 0.001 Social 52.59 ± 18.81 67.10 ± 12.85 < 0.001 Environmental 44.03 ± 14.02 59.01 ± 8.86 < 0.001 QOL: quality of life , DM : diabetes mellitus Table( 8): Comparison of overall QOL value (OQOL) between patients groups and control group Patients group Value of (OQOL) for patients group Value of (OQOL) for Control group p- value DM patients 50.03 ± 14.94 63.99 ± 8.19 < 0.001 Hypertensive patients 52.53 ± 11.86 63.99 ± 8.19 < 0.001 DM plus hypertension 45.94 ± 15.10 63.99 ± 8.19 < 0.001 OQOL : overall quality of life , DM : diabetes mellitus Table( 9): Comparison value of (OQOL) between patients groups First group OQOL (Mean ±SD) other group OQOL (Mean ±SD) p- value DM 50.03 ±14.94 Hypertension 52.53±11.86 0.08 DM plus hypertension 45.94± 15.10 DM 50.03 ±14.94 0.02 DM plus hypertension 45.94± 15.10 Hypertension 52.53±11.86 < 0.001 OQOL: overall quality of life, DM: diabetes mellitus Iraqi J Pharm Sci, Vol.26(2) 2017 Patients with diabetes mellitus, hypertension or both diseases 38 Discussion This study showed that DM has significant impact on all domains of QOL as compared to control group and this supported by other studies like Ashraf Eljedi et al. (24) and Zivcicova et al. (25) and the physical domain was affected to greater extent than other domains and this consistent with Ahari et al. (26) and Boon- How Chew et al. (27). The social domain is affected to minor extent than other domains probably due to prevalence of social support for these persons and this also supported by Boon- How Chew et al. (27). Hypertension affects all aspects of QOL. The scores of four domains in hypertensive patients are significantly (p < 0.001) lower than the scores of control group where the physical domain is affected more while the social domain is least affected among all domains of WHOQOL-BREF questionnaire and this result is consistent with the result obtained in Brazil (28) and Xianglong Xu et al. that represent that the HQOL is significantly affected by hypertension although it use another instrument for measurement of QOL like SF-36 (29). The presence of T2DM and hypertension in same individual further lower the scores of QOL than DM or hypertension alone where the scores of all domains is significantly very lower than the scores of these domains in healthy individuals due to burden of both disease and its complications and treatment on patients quality of life. When the patient suffers from single chronic illness, the only perception of being have chronic disease is enough to compromise the QOL (30, 31). The T2DM alone and hypertension alone produce comparable effect on QOL where the mean of overall QOL (OQOL) of diabetic patients is (50.03) whereas the mean of (OQOL) of hypertensive patients is (52.53) and the (p > 0.05) and this is supported by Tamara Poljicanin et al. study (32). The mean score of (OQOL) of diabetic hypertensive patients is poorer than that for patients with T2DM alone or hypertension alone and this consistent with the result obtained by Hwee-Lin Wee et al. (33). The present study indicate that the combination of T2DM and other chronic non-communicable disease like hypertension can further lower the scores of QOL domains especially physical domain which is decreased to greater extent than other domains and this is supported by Otiniano ME et al. (34) and Oldridge NB et al. (35). Also the participants of this study were drawn from general population so the findings of this study can be easily generalized to large scale population (36). Also the results of this study indicate that the presence of T2DM and hypertension not only rise the healthcare costs (37) and mortality (38) but also increase the physical and psychological load of these diseases on patients. The strengths of this study are use of generic questionnaire which explain the wider effect of DM and hypertension on various aspects of life. The WHOQOL-BREF was characterized by good reliability and acceptable validity in cross-sectional studies over 23 nations (39). Other factors that strength this study is relatively large size sample and presence of control group. Conclusion According to the results obtained from this study, it can be concluded that patients with T2DM alone have significant lowering of mean scores of all domains of QOL and mean of overall QOL compared to control group with physical domain was highly affected and social domain was least affected. Also, hypertension alone has significant negative impact on QOL. While the diabetic hypertensive patients have poorer QOL than control group. The hypertension and T2DM have comparable impact on QOL; while the presence of T2DM plus hypertension negatively affects all domains of QOL to greater extent than T2DM alone or hypertension alone. The benefits of this study are: (1) determination of impact of chronic diseases like diabetes mellitus or hypertension on health related quality of life which considered as indicator for health outcome, (2): comparison of effect of presence of two chronic diseases in same patients versus one chronic disease (3) determine the aspects of life that were influenced by presence of diabetes and hypertension and determine which aspect is affected to greater extent (4) indicate that great attention is required for patients with diabetes or hypertension by activation of screening system for early detection of diabetes and hypertension and so enable for prevention, prevent the progression , and treatment of such diseases and its complications (5) this study determine that patients with diabetes or hypertension have poor quality of life and so further investigation is required to determine the causes and so improve the QOL of such patients. 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