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Bioidentical Hormone Restoration Best Medical Practice

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1 Bioidentical Hormone Restoration Best Medical Practice

2 Hormones Neuro-endocrine-immune system Travel via blood to cells receptors Control cells proliferation, protein manufacture, metabolic rate, etc. Most powerful molecules in our bodies Optimal levels essential for health and quality of life


4 Hormones and Aging Why Doctors Dont Get It

5 Bioidentical Hormone Restoration is Common Sense If a hormone is missing, replace it! If present but insufficient, optimize it! Type 1 Diabetes: bioidentical insulin Hypothyroidism: bioidentical T 4 Growth hormone def.: bioidentical GH Adrenal insufficiency: bioidentical cortisol But what about hormones lost to aging?

6 PregnenoloneMother Steroid J Clin Endocrinol Metab. 1997 Aug;82(8):2396-402.

7 DHEA DHEA-S J Clin Endocrinol Metab. 1997 Aug;82(8):2396-402.

8 Growth Hormone (GH) Somatopause J Clin Endocrinol Metab. 1999 Jun;84(6):2013-9. Normal Adults Pituitary Disease fatigue Sufficiency Log scale

9 Testosterone Progesterone Estradiol pg/ml DHEA–10,000 pg/ml, DHEA-S 5,000,000 pg/ml ! Andropause Menopause

10 Hormonal Changes With Aging Hormones that build tissues and improve immunity decline with age by 50-80% (DHEA, Testosterone, GH) Progesterone starts to decline at age 30. Estradiol disappears at 50menopause Thyroid hormone production and sensitivity decline Insulin output declines Diabetes By age 5020 years of hormonal deficiency

11 Conventional View of Hormones and Aging The loss of hormones is adaptive–helps us to live longer Persistence of youthful levels of hormones would cause more heart attacks and cancers as we age Losing our hormones is good for us(?!) Fits the Pharmaceutical Agenda: Take drugs for every symptom and disorder caused by hormone loss!

12 Against the Conventional View Aging is a self-destruct program that kicks in at age 25 in humans Aging is natural degeneration! Weight gain, high blood pressure, high cholesterol, cancers, heart attacks, autoimmune diseases, etc. occur years after hormone deficiencies begin and occur more often in people with lower hormone levels! Studies of balanced hormone restoration show the expected benefits and no proof of harm!!

13 Example: Growth Hormone Declines 14% per decade after age 25 IGF-1 of many adults equal to hypopituitary patients (only 80-110 vs. 350 @25yrs.old) Deficiency heart disease, frailty, depression, body fat, bone loss GH restoration reduces abdominal fat, lowers blood sugar and blood pressure Improves cognition, mood, sleep, energy Increases muscle, decreases fat & cholesterol Improves bone density, skin thickness Downside: high cost, nightly injections

14 The Endocrinology of Aging Endocrine glands and their feedback control systems deteriorate with age Our bodies cease to regulate our hormones for optimal health Hormone losses speed our general deterioration: a vicious cycle. The symptoms of hormone loss are warning signs of physical deterioration Win-Win: Hormone restoration makes you feel better and improves your health!

15 Since the Loss of Hormones is Harmful,THEN… Restoring youthful hormone levels is: essential preventative medicine essential to the treatment of disease essential to Quality of Life! We have the need and the right to restore hormones lost to aging!

16 Hormones and Aging Any Questions?

17 Human Steroid Hormones Testosterone Estradiol Progesterone Cortisol DHEA

18 Where Do They Come From? All steroid hormones (including substitutes) are chemically synthesized from diosgenin (wild Mexican yams, soy, and other plants).

19 Not Just Sex Hormones Estrogen, progesterone, testosterone and DHEA essential to cellular growth and function in all tissues in both sexes! Maintain brain functionmodulators of mood, cognition, pain, etc. Maintain the immune systemprogesterone and testosterone are immunosuppressants Maintain connective tissue: skin, hair, bone, muscle, and blood vessels

20 Female Endocrinology Nature makes special demands on the female body for reproduction Breast, uterine and ovarian tissues undergo a monthly cycle of proliferation, differentiation, and breakdown Defects in this cycle can lead to cancers in female organs and to many medical disorders.

21 EstrogenProgesterone Complementarity Estrogen promotes breast/uterine tissue proliferation and growth Progesterone stops proliferation and promotes maturation and differentiation Differentiated cells cant become cancer cells High average progesterone/estrogen ratio suppresses proliferation and prevents cancers of female organs

22 Progesterone Deficiency Estrogen Dominance Allergies Autoimmune diseases Anxiety, irritability Insomnia Decreased sex drive Depression Bloating and edema Fibrocystic breasts Uterine fibroids Breast cancer Ovarian cancer Uterine cancer Thyroid dysfunction Gallbladder disease Heavy periods Migraines Seizures Progesterone and Iodine/Kelp reduce estrogen dominance

23 Historical Perspective Throughout most of human history, women were usually: Pregnanthigh progesterone Breastfeedinglow estrogen (both protect against breast cancer) Women cycled for 4 years avg.; today many cycle for 35 years Cycling= risk of estrogen dominance and other hormonal disorders

24 Perimenopause Females born with a fixed no. of oocytes which are continually lost to age and ovulation With aging, fewer oocytes of lower quality are left reduced progesterone production beginning around age 30 estrogen dominance No ovulation=no progesterone Estrogen swings from very high to very lowoften for several years.

25 Normal Progesterone Dominance Ovulation Menstrual Cycle

26 Perimenopause Luteal Insufficiency=Estrogen Dominance Ovulation Menstrual Cycle Inadequate Luteal Phase shorter periods, early spotting

27 Perimenopause Anovulation=Estrogen Dominance Menstrual Cycle

28 Menopause Estrogen and Progesterone Deficiency

29 Also Uterine and Ovarian Cancer

30 Menopause Estrogen Deficiency Progesterone Deficiency Testosterone Deficiency After menopause, women depend upon their adrenal glands for androgens and estrogens, so: Menopause +Adrenal Insufficiency =BIG TROUBLE

31 Effects of Combined Sex- Hormone Deficiency Irritability, insomnia, brain dysfunction Alzheimers dementia Fatigue, aches and pains. Osteoporosis fractures, loss of teeth Genital atrophy, vaginal dryness Atrophy of skin and connective tissue Heart diseasehigher risk than men after 65, higher mortality after 70!

32 Estradiol Restoration Eliminates hot flashes Restores mood and mental function Probably protects against Alzheimers disease Maintains genital/vaginal skin and lubrication Increases thickness, fullness of skin and hair Prevents heart disease Prevents colon cancer and macular degeneration Improves insulin sensitivityhelps diabetes Prevents osteoporosis and osteoarthritis

33 Speroff L, Fritz M Clinical Gynecologic Endocrinology and Fertility, 7 th Ed.

34 Osteoporosis In menopause 5% bone loss each year for first 5 years=25%all due to loss of estrogen! 20 yrs. post menopause50% reduction in trabecular bone, 30% in cortical bone 50% of women >65 yrs. old have spinal compression fractures 14% lifetime risk of hip fracture for 50 yr.old woman, 30% for 80 yr. old. Speroff L, Fritz M Clinical Gynecologic Endocrinology and Fertility, 7 th Ed.

35 Osteoporosis A hormone deficiency diseasethe proper treatment is hormone restoration! Estrogen prevents resorption of old bone while testosterone, progesterone, DHEA and GH build new bone J Clin Endo Metab. 1996; 81:37-43. J Reprod Med. 1999 Dec;44(12):1012-20. Combined BHR increases bone density far better than Fosamax and preserves normal bone remodeling (no rotting jaw, eye inflammation, Ca ++ ).

36 Estrogen, Progesterone, and Osteoporosis Any Questions?

37 Total and Free Testosterone in Men Baltimore Longitudinal Study of Aging (BLSA). Harman et al., 2001

38 Andropause in Men

39 Testosterone Restoration Improves mood and sociability Restores energy and ambition Improves cognition Increases libido and sexual performance Increases muscle and bone mass Reduces abdominal fat, improves insulin sensitivity, lowers blood pressure--counteracts metabolic syndrome

40 Testosterone and the Heart Low testosterone levels, correlate with coronary artery disease and stroke Arterioscler Thromb. 1994; 14:701-706 Eur Heart J 2000; 21; 890–4 Int J Cardiol. 1998 Jan 31;63(2):161-4 Arterioscler Thromb Vasc Biol. 1996 Jun;16(6):749-54 T dilates coronary arteriesimproves angina T increases heart muscle size, strength T decreases fibrinogen levelsprevents blood clots Endocr Res. 2005;31(4):335-44.

41 Testosterone and the Prostate Higher testosterone levels do not increase the risk of prostate cancer. Studies of testosterone supplementation have shown no increase in prostate cancereven though so many men have it! Low testosterone correlated with more aggressive prostate cancers Testosterone promotes prostate growth to a point, but not prostate cancer

42 Wheres the Beef? These results argue against an increased risk of prostate cancer with testosterone replacement therapy. Testosterone replacement therapy and prostate risks: where's the beef? Can J Urol. 2006 Feb;13 Suppl 1:40-3.

43 Estrogen Dominance Theory of Prostate Disease In many men, free testosterone declines > estradiol Estrogen dominance is a probable cause of prostrate enlargement and a possible cause of prostate cancer Elevated estrogen/Test. ratios in BPH Scandinavian Journal of Urology and Nephrology, 1995; 29: 65-68. High levels of estradiol and estrone found in BPH tissues Estradiol upregulates oncogenes

44 Female Andropause Young womans free testosterone level in serum is 2x her free estradiol Female testosterone levels decline 50% between age 20 and 45 Birth control pills testosterone and DHEA levels DHEA declines with agemain source of androgens in women

45 Testosterone for Women Improves energy, mood Improves sexual desire and response Increases muscle strength and reduces muscle and joint aches With estradiol, increases bone density J Reprod Med. 1999 Dec;44(12):1012-20. Probably decreases risk of heart attack J Womens Health. 1998 Sep;7(7):825-9. Given with estradiol and progesterone, reduces risk of breast cancer Menopause. 2003 Jul-Aug;10(4):292-8, Endocr Rev. 2004 Jun;25(3):374-88. Menopause. 2004 Sep-Oct;11(5):531-5, FASEB J. 2000 Sep;14(12):1725-30.

46 Testosterone Any Questions?

47 My doctor says that hormone replacement is dangerous and theres no evidence that bioidentical hormones are safer!

48 Two Approaches to Medicine Natural-ScientificIdentify the deficiency/excess at the molecular level and correct it with bioidentical molecules PharmaceuticalCreate non-natural, patentable substances that will produce some improvement Natural Science should be primary; Pharmaceutical Science secondary.

49 Problems with Pharmaceuticals Alien molecules: not recognized, not easily eliminated Negative functions: disrupt normal physiology by blocking receptors, inhibiting enzymes, etc. Toxic: 1. Side effects even at low doses 2. Allergic reactions 3. Long-term damage

50 Pharmaceutical Billions Mission: Sell pharmaceuticals Information controljournals, CME, med. schools, professional org.s, etc. Strategy: Suppress competition (natural vitanutrients and hormoneshuman physiology!!) Conventional Docs: Unaware Result: Unfounded fear of hormone optimization; unfounded confidence in toxic drugs

51 History of Hormone Replacement Therapy Horse-derived Premarin approved in 1942 Progesterone synthesized in 1942. Poorly absorbed orally Chemically altered to make progestins among the first drugs to be patented. HRT came to mean the use of alien molecules that had hormone-like effects Drug co.s became dependent on HRT profits Drug co.s push doctors to use hormone substitutes and to ignore or fear natural hormones!!

52 Dirty Secret: Conventional HRT is really HST! Progesterone substitutes: medroxyprogesterone acetate (MPA- Provera ) and 30+ other progestins Estradiol substitutes: conjugated equine estrogens (CEE-Premarin ) and ethinyl estradiol (birth control pills) Testosterone substitute: oral methyltestosterone Patented drugsnot hormones! Most docs dont know the difference!

53 Premarin Conjugated Equine Estrogens (CEE) Estradiol-17β Dihydroequilin-17β CEE contains at least 10 estrogens, only 3 are human. CEE contains 3x more Dihydroequilin than Estradiol. DHE has 10% higher binding affinity for est. receptors. DHE binds far less to SHBG and has a slower metabolic clearance The most abundant estrogen in CEE is Equilin sulfate. Kuhl H, Climacteric 2005;8(Suppl 1):3–63 Human Horse

54 Estradiol Ethinyl estradiol EE cannot be inactivated by normal oxidation! EE does not interact with estrogen receptor ! EE is 12,000-60,000 times more potent by weight! EE is much more thrombogenic than estradiol EE in Birth Control Pills Acetylene

55 Progesterone vs. Progestins Progesterone MPA (Provera ) Megestrol Every progestin has a different spectrum of androgenic, estrogenic, glucocorticoid, and progestational effects!

56 Progestin Zoo Kuhl, Climacteric 2005;8(Suppl 1) Progesterone NAMS-Call em all Progestogens

57 Testosterone Substitution Testosterone Methyltestosterone Methyltestosterone (in Estratest ) aromatizes to an alien estrogen and increases risk of breast cancer, also causes liver damage and breast enlargement in bodybuilders Headlines: Testosterone therapies increase risk of breast cancer.

58 Sex Bias If a Mans testes are removed or non- functional, bioidentical testosterone replacement is started immediately If a womans ovaries are removed or non- functional, she is offered horse hormones or hormone-like drugs; or is told to Live with it. It IS a Mans World!

59 Birth Control Hormone Substitution is Dangerous 2x risk of stroke, heart attack 2-30x risk of blood clots 1-3x risk of breast cancer Increased blood sugar, blood pressure 1.5x risk systemic lupus erythematosis Liver tumors Diagnose and fix the hormonal disorder Use a copper IUD for contraception!! UpToDate 2006 Instead::

60 2002 WHI StudyMenopausal Prempro HST is Dangerous! Oral CEE (Premarin ) alone had adverse effects in the first year (strokes, blood clots) Adding MPA (Provera, PremPro ) caused more adverse effects (breast cancers, heart attacks) CEE/MPA caused a large increase in dementia And we know why these forms of hormone substitution are dangerous!

61 Dangers of Oral Estrogen Replacement First-pass effect on the liver IGF-1, SHBG, CRP, clotting factors blood clots, strokes, heart attacks in the first year Smokers have greater risk of clots EE increases clotting much more than estradiol, Premarin ® Transdermal estradiol has none of these effects!

62 Dangers of Estrogen-only HRT Estrogen alone, estrogen-progestin HST and BCPs all reduce DHEAS and testosterone levels 25-60% Estrogen without progesterone and testosterone estrogen dominance and risk of breast cancer and other medical disorders

63 Provera Progesterone Maintains pregnancy Improves mood Improves sleep Diuretic Lowers blood sugar Maintains estrogen-induced arterial dilation Improves lipid profile No evidence of CVD Reduces estrogenic stimulation of breasts Prevents breast cancer Causes birth defects Can cause depression Insomnia, irritability Fluid retention Raises blood sugar Counteracts estrogen- induced arterial dilation Worsens lipid profile Causes heart attacks Increases estrogenic stimulation of breasts Causes breast cancer Progestins are Dangerous Scientific studies show that:

64 Atherosclerosis and Clotting In both peripheral and cerebral vasculature (of live animals), synthetic progestins caused endothelial disruption, accumulation of monocytes in the vessel wall, platelet activation and clot formation, which are early events in atherosclerosis, inflammation and thrombosis. Natural progesterone or estrogens did not show such toxicity. Climacteric. 2003 Dec;6(4):293-301

65 Progesterone and Breast Cancerthe Evidence Premenopausal women with low P levels had 5.4 times greater risk of early breast cancer, 10x greater risk for all cancers Am J Epidem 1981;114:209-17. Breast cancer victims have signs of progesterone resistance Br J Obstet Gynaecol. 1998 Mar;105(3):345-51. P downregulates BRCA1 and induces apoptosis in breast cancer cell lines. Anticancer Res. 2005 Jan-Feb;25(1A):243-8.

66 Progesterone and Breast Cancerthe Evidence cont. Estrogen cream applied to the breast induces proliferation, adding progesterone cream reduces proliferation to baseline Fertil Steril 1995; 63:785-91 Estrogen is carcinogenic in breast cell cultures unless progesterone is present J Steroid Biochem Mol Biol. 2003 Oct;87(1):1-25. Estrogen upregulates cancer-promoting gene bcl-2, progesterone downregulates it. Ann Clin Lab Sci. 1998 Nov-Dec;28(6):360-9.

67 E3N-EPIC Study Bioidentical estradiol plus progesterone decreased the risk of breast cancer! Int J Cancer. 2005 Apr 10;114(3):448-54. Cohort study 54,000 women 5.8 years f/u c/w WHI-- 16,000, 6 yr. f/u No Evidence that BHRT is safer?

68 ORDET Study Int. J. Cancer 112 (2004) (2), pp. 312–318. Higher progesterone=lower risk of breast cancer 6,000 women 5 yr. F/U

69 Progesterone and Breast CancerConclusion The balance of the in vivo evidence is that progesterone does not have a cancer- promoting effect on breast tissue. J Steroid Biochem Mol Biol. 2005 Jul;96(2):95-108 In fact, the balance of the evidence indicates that progesterone protects against breast cancer! So…women can be given estradiol as long as its balanced by progesterone and testosterone!

70 Pharmaceutical Corps Dilemma They need to control the HRT market Their progesterone and estradiol substitutes are dangerous They cant patent natural hormones Pharm. Corps. have to get FDA-approval for every natural hormone preparation $$$ Compounding pharmacies can dispense natural hormones cheaply

71 Pharm. Corps Choices Stop compounding pharmacies so they can control of the BHR market Wyeths appeal to the FDA, media propaganda blitz Suppress BHR in favor of their substitutes Keep looking for substitutes that will provide benefits without risks Result: Your doctors will never learn the truth about hormones unless he/she goes looking for it

72 Common Sense Substitutes are alien molecules! Problems caused by hormone substitutes cannot be attributed to human hormones until proven otherwise. Bioidentical hormone restoration should be considered safe until proven otherwise!

73 Hormone Substitution Any Questions?

74 Metabolic Regulators: Thyroid and Cortisol Thyroid sets throttle, cortisol delivers fuel Deficiency reduced metabolic rate fatigue, brain dysfunction, depression, pain Subtle deficiency symptoms and disease Usual blood tests are insensitive Irrational fear of supplementation Underdiagnosed, undertreatedDocs prescribe pharmaceuticals (SSRIs) instead

75 Hormone Ignorance: the Tyranny of the Lab Report Reference Range=95% of normal people optimum Male free testosterone: 35-155 5x Female free testosterone: 0.0-2.2 Free T3: 1.8-3.2 2x TSH: 0.3-5 17x If within normal limits no diagnosis; pharmaceuticals for symptoms If below normal, just replace to WNL

76 HypothyroidismSymptoms Mental fog, depression, anxiety Fatigue Cold extremities Aches and pains Hair falling out Weight gain Constipation Self-Test: Basal body temperature <97.8°F axillary in bed in AM

77 Thyroid HormoneT 3 Maintains metabolism, mood, and energy Controlled partly by thyroid stimulating hormone (TSH) from the pituitary gland TSH test is indirect: does not measure T 3 levels or effects in various tissues Docs prescribe T 4 only (Synthroid and Levoxyl )prohormone that must be converted to T 3 Docs rarely measure free T 3 levels!

78 We Need Optimal T 3 Levels Incidence of severe atherosclerosis doubled with lower T 3 or higher TSH levels within the normal range Clin Cardiol. 2003 Dec;26(12):569-73 Lowers cardiac risk factors: cholesterol, triglycerides, C-reactive protein, homocysteine and lipoprotein(a) Lowers blood pressure, dilates arteries Reduces tendency to form blood clots Prevents weight gain

79 Fatigue, Fibromyalgia and Depression Epidemic Pre-TSH: Treat the patient s symptoms Post-TSH: Treat the test (?) 1970s Doctors lowered doses by 30% TSH-normalizing T 4 dose low T 3 levels! Williams Textbook of Endocrinology. Saunders, Philadelphia, pp 357-488) T 3 alone often effective in fibromyalgia T 3 alone relieves depression even if tests normal! J Affect Disord. 2006 Feb

80 Rational Approach to Thyroid Restoration If S/S of hypothyroidism: Treat! Give T 4 plus T 3 (Armour, Cytomel) Endocrinology 1996;137:2490-2502 Increase dose until symptoms gone or S/S of excess appear Safe--even moderate TSH suppression does not cause: bone loss Horm Res. 2005;64(6):293-8. Epub 2005 Nov 1. cardiac abnormalities J Clin Endo Metab. 2000 Jan;85(1):159-64. muscle wasting Am J Phys Endol Metab. 2005 Jun;288(6):E1067-73.

81 Pharmaceuticals, Labs, and Thyroid Any Questions?

82 Cortisol Made in the adrenal glands Maintains blood sugar (delivers the fuel) Modulates immune system Need high amounts when stressed Too much Diabetes, HTN, osteoporosis Too little hypoglycemia, fatigue, autoimmune diseases, aches and pains

83 Cortisol Deficiency Fatigue, depression Aches and pains Cant stay asleep Cant deal with exercise, stress, or illness 2 nd wind late at night Hypoglycemia, feels better after eating Nausea, abdominal discomfort, diarrhea Allergies, autoimmune diseases Hard to gain, hard to lose weight Low blood pressure, salt and sugar cravings

84 Mild-to-Moderate Cortisol Deficiency Blood tests are insensitive, need diurnal salivary cortisol profile Underdiagnosed: Docs taught only about severe adrenal insufficiency due to physical destruction of the adrenal glands (Addisons Disease) or pituitary Common cause of chronic fatigue, pain Clue: Felt great when taking prednisone

85 Normal Saliva Cortisol Profile

86 Cortisol Deficiency

87 Cortisol DeficiencyNormal Waking Cortisol

88 DepressionElevated PM Cortisol

89 Cortisol Restoration Mild deficiency can resolve with stress, rest, nutrient restoration Moderate-to-severeneed cortisol, not cortisol substitutes like prednisone Physiological doses (5 to 20mg=<1-4mg prednisone)NOT excessive doses that cause hypertension, diabetes, osteoporosis, etc. Fears of low-dose cortisol unfounded Dr. William Jeffries Safe Uses of Cortisol

90 DHEAThe Other Adrenal Hormone Most abundant steroid hormone yet ignored Cells make testosterone and estradiol with it Levels decline with age, stress and disease Anabolicbuilds tissues, improves immunity Reduces abdominal fat Reduces painrestores natural endorphins Reduces inflammation ( IL-6, TNF-, IL-2) Anti-cancer effect in animal, in vitro studies Lower levels assoc. with disease, mortality

91 Fatigue, Depression, and Pain Should be considered as due to a nutrient, thyroid, cortisol, or DHEA deficiency until proven otherwise by testing and by trials of nutrient and hormone restoration.

92 Cortisol and DHEA Any Questions?

93 What Else Can Hormone Replacement Help? Infertility, PMS, heavy bleeding Insomniaalmost always helps Heart failure Mental disorders Autoimmune diseases (systemic lupus erythematosis, rheumatoid arthritis, ulcerative colitis, Crohns disease, etc.) Allergies, skin diseases

94 Hormone Restoration Unresolved issuesmore investigation needed Need more long-term randomized studies to study long-term results Questions about delivery and monitoring Medical profession should be studying bioidentical hormones instead of hormone substitutes!

95 Local Compounding Pharmacies Winola PharmacyRt. 307 at Lake Winola, 378-2885 Harrolds PharmacyWilkes-Barre, 822- 5794 Finos PharmacyDallas, 675-1141 Hazle Drugs ApothecaryHazelton phone 1-800-439-2026

96 Doing BHRT History, consent, fees online Initial visit: order tests F/U visit: Resultsprescriberetest Repeat until stabilized at proper dose Follow-up office visit once every 6 months, test only as needed. Telephone and e-mail contactcharges for clinical decisions, refills, etc.

97 Costs Physician time only as required--first year ~$200-$400; then <$200/yr. No insurance billing; may submit claim for recognized diagnosis Hormones$10 to $70/month, some covered by insurance (GH adds $130/mo.) Diurnal salivary cortisol test$120 Blood testsinsurance may pay, lab kits $170-$220, Saliva/blood kit$299 Out-of-pocket expenses tax-deductible

98 For More Information The Miracle of Natural Hormones David Brownstein, MD How to Achieve Healthy AgingLook, Live, and Feel Fantastic After 40 Neal Rouzier, MD The Hormone SolutionStay Younger Longer Thierry Hertoghe, MD Life Extension Foundation ( BHRT info. and hundreds of abstracts at Contact me:

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