Bioidentical Hormones

Bioidentical Hormones

“It’s important to note that custom-compounded
bioidentical hormone therapy is NOT recommended
because it lacks regulation, rigorous safety and…”.1

Umbrella
What may the Bioidentical Hormones Umbrella include?

Depending on the Source (DotS) this Umbrella may include:

  • Bioequivalent Hormone Therapy
  • Bioidentical Hormone Medications
  • Bioidentical Hormone Replacement Therapy (BHRT)
  • Bioidentical Hormone Therapy (BHT)
  • Bioidentical Hormones
  • Bioidenticals
  • Custom-Compounded Bioidentical Hormone Therapy (C-CHT)
  • Custom-Made Bioidentical Hormones
  • Custom-Mixed Bioidentical Hormones
  • Hormone Therapy Alternatives
  • Natural Hormone Therapies
  • Pharmacy Compounded Hormones
  • ‘Compounded’ Bioidentical Hormone Replacement Therapy (cBHRT)
  • ‘Regulated’ Bioidentical Hormone Replacement Therapy (rBHRT)

Date

What can it be important to be clear about with bioidentical hormones information?

It can be important to be clear about the date of all information including the date of bioidentical hormones information, because this information may have been updated.

Symptoms or Chronic Conditions

What can it also be important to be clear about with bioidentical hormones information?

It can also be important to be clear about whether bioidentical hormones information is about the use of bioidentical hormones for the management of menopausal symptoms such as hot flushes, night sweats and vaginal dryness or for the prevention of chronic conditions such as cardiovascular disease, cancer and osteoporosis.

Bioidentical Hormones

What are bioidentical hormones?

DotS the definition of bioidentical hormones may vary. On page one in Menopausal Hormone Therapy the European Menopause and Andropause Society’s definition is:

“‘Bioidentical hormones’ is a term used to describe plant-derived preparations (like approved MHT drugs) modified to be structurally identical to human hormones such as estradiol and progesterone”.2

Bioidentical Hormone Therapy

What is bioidentical hormone therapy?

DotS the definition of bioidentical hormone therapy may vary. In Bioidentical Hormones: Are They Safer? Are bioidentical or natural hormones safer and more effective than hormones used in traditional hormone therapy for menopause symptoms? the (United States) Mayo Clinic author’s definition is:

“The term “bioidentical” means the hormones in the medicine are chemically the same as those the body makes. In fact, the hormones in bioidentical medicines may not be any different from those in traditional hormone therapy. In the United States, many hormone therapy medicines approved by the Food and Drug Administration (FDA) and prescribed by healthcare professionals have bioidentical hormones in them”.3

On page 771 in The 2022 Hormone Therapy Position Statement of The North American Menopause Society, published July 2022, and endorsed by multiply organizations, the North American Menopause Society (NAMS) (now the Menopause Society) explain:

“The term bioidentical hormone therapy (similar to endogenous) can be misleading because there are both government-approved and compounded bioidentical hormone therapies. Government approved (in the United States, FDA-approved) bioidentical hormones include estradiol, estrone, and MP, which are regulated and monitored for purity and efficacy. These are dispensed with package inserts containing extensive product information (based on RCTs) and may include black-box warnings for AEs. In contrast, compounded bioidentical hormone therapies are prepared by a compounding pharmacist using a provider’s prescription. These therapies may combine multiple hormones (estradiol, estrone, estriol, DHEA, testosterone, progesterone) and use untested, unapproved combinations or formulations or are administered in nonstandard or untested routes such as subdermal implants, pellets, or troches”.4

Hormone Testing or Not

Is serum, saliva or urine hormone testing necessary to prescribe bioidentical hormones?

On page 771 in The 2022 Hormone Therapy Position Statement of The North American Menopause Society the NAMS note:

“Compounded bioidentical hormone therapy has been prescribed or dosed on the basis of serum, salivary, or urine hormone testing; however, the use of such testing to guide hormone therapy dosing is considered unreliable because of differences in hormone pharmacokinetics and absorption, diurnal variation, and interindividual and intraindividual variability”.5

cBHRT

What is cBHRT (Compounded Bioidentical Hormone Replacement Therapy)?

DotS the definition of cBHRT may vary. In Bioidentical HRT: Summary of Key Terminologies the British Menopause Society’s (BMS) definition is:

“cBHRT: Compounded Bioidentical Hormone Replacement Therapy: Precise duplicates of human hormones which are produced by specialist pharmacies and do not follow the same MHRA regulatory pathway as conventional rBHRT”.6

rBHRT

What is rBHRT (Regulated Bioidentical Hormone Replacement Therapy)?

DotS the definition of rBHRT may vary. In Bioidentical HRT: Summary of Key Terminologies the BMS’s definition is:

“rBHRT: Regulated Bioidentical Hormone Replacement Therapy: Precise duplicates of human hormones developed in a conventional way by the pharmaceutical industry and authorised by the regulators such as the MHRA in the UK”.7

What is MHRA?

In this context MHRA can be an abbreviation for the (United Kingdom) Medicines & Healthcare Products Regulatory Agency.

Approved or Not

Are compounded bioidentical hormones approved by individual Country Drug Regulatory bodies for example the FDA?

In Compounding and the FDA: Questions and Answers – Are Compounded Drugs Approved By FDA? the (United States) Food and Drug Administration (FDA) elaborate on:

“Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed. Consumers and health care professionals rely on FDA’s drug approval process for verification of safety, effectiveness and quality”.8

Natural or Not

Are bioidentical hormones natural?

In Bioidentical Hormones: Are They Safer? Are bioidentical or natural hormones safer and more effective than hormones used in traditional hormone therapy for menopause symptoms? the Mayo Clinic author explains:

“The term “natural” means the hormones in the medicine come from plant sources. They’re not created in a lab right from the beginning. But many of these substances still need to be processed by a commercial lab to become bioidentical”.9

In Treatments for Menopause: Menopausal Hormone Therapy (MHT) – What Are Bioidentical Hormones? the (Australian) Jean Hailes for Women’s Health (JH) note:

Bioidentical Hormones“Some doctors prescribe bioidentical hormones, which are mixtures of different hormones made up in compounding pharmacies. The hormones, which are available as capsules, creams, gels, drops and lozenges, are promoted as ‘natural’ and ‘exactly like our own’, but this is not true.

Hormones are only natural when they are produced in the human body.

Pharmacy-compounded hormones have no government controls or regulations, and little to no high-quality research into their safety and effectiveness”.10

Safe or Not

Are bioidentical hormones safe?

In Bioidentical Hormones: Risks and Benefits – What Are the Risks of Bioidentical Hormones?, published 15 May 2022, the (United States) Cleveland Clinic elaborate on:

“Many healthcare providers who use bioidentical hormones claim they are safer than traditional hormone therapy treatments. But there have been no large research studies of bioidentical hormones to show evidence of this”.11

On page 771 in The 2022 Hormone Therapy Position Statement of The North American Menopause Society, published July 2022, and endorsed by multiply organizations, the NAMS explain:

“There is a dearth of safety and efficacy data with little or no high-quality pharmacokinetic data to provide evidence of safety and efficacy of compounded bioidentical hormone therapy and insufficient evidence to support overall clinical use of compounded bioidentical hormone therapy for treatment of menopause symptoms. Compounded bioidentical hormone therapy presents safety concerns, such as minimal government regulation and monitoring, overdosing and underdosing, presence of impurities and lack of sterility, lack of scientific efficacy and safety data, and lack of a label outlining risks”.12

Recommended or Not

Hormone TherapyDo menopause societies and other organizations, recommend the use of bioidentical hormones?

On page four in the International Menopause Society’s Leaflet for Women for World Menopause Day on 18 October Menopause and Menopause Hormone Therapy: 2. What Is MHT? the International Menopause Society note:

“It’s important to note that custom-compounded bioidentical hormone therapy is NOT recommended because it lacks regulation, rigorous safety and efficacy testing, batch standardization, and purity measures”.13

In Treatments for Menopause: Menopausal Hormone Therapy (MHT) – What Are Bioidentical Hormones?, last updated 13 May 2025, the JH include:

“We do not recommend the use of pharmacy-compounded menopause hormone therapy”.14

In Bioidentical HRT: Summary of Key Terminologies, reviewed March 2024, the BMS note:

  • “cBHRT products are not recommended by the BMS they are not evidence based for effectiveness and safety and because rBHRT options are available”.15

In The 2023 Practitioner’s Toolkit for Managing Menopause: Management – Considerations for All Women At Menopause: Menopausal Hormone Therapy, published online 30 October 2023, the authors also note:

  • “The prescription of individually formulated and compounded hormone preparations is not recommended”.16

In Hormone Replacement Therapy (HRT): Alternatives To Hormone Replacement Therapy (HRT) – Herbal Remedies and Complementary Medicines for Menopause Symptoms: Bioidentical or “Natural” Hormones, last reviewed 07 February 2023, the (United Kingdom) NHS explain:

“Bioidentical hormones are made from plant sources and are described as being similar or identical to human hormones.

Some people claim that these hormones are a “natural” and safer alternative to standard HRT medicines.

However, bioidentical hormones are not recommended because:

  • They’re not regulated and it’s not clear how safe they are – there’s no good evidence to suggest they’re safer than standard HRT
  • It’s not known how effective they are in reducing menopause symptoms
  • The balance of hormones used in bioidentical preparations is usually based on the hormone levels in your saliva, but there’s no evidence that these levels are related to your symptoms”.17

On page four in the Joint Position Statement By the British Menopause Society, Royal College of Obstetricians and Gynaecologists and Society for Endocrinology on Best Practice Recommendations for the Care of Women Experiencing the Menopause, first published online 10 June 2022, one of the recommendations is:

  • “The use of compounded bioidentical hormone replacement therapies is not recommended given the issues related to their purity, potency and safety. The potential benefits of bioidentical hormone therapy can be achieved using conventionally licensed products available through NHS prescribing without having to resort to compounded varieties from specialist pharmacies”.18

Body Identical Hormones

Are body identical hormones available?

In Hormone Replacement Therapy (HRT): Alternatives To Hormone Replacement Therapy (HRT) – Herbal Remedies and Complementary Medicines for Menopause Symptoms: Bioidentical or “Natural” Hormones the NHS note:

“Body identical hormones are different. Because they have been regulated, tested and thoroughly researched, they can be prescribed to treat menopause symptoms”.19

Government Approved

Are government approved bioidentical hormones available?

In Bioidentical Hormones: Are They Safer? Are bioidentical or natural hormones safer and more effective than hormones used in traditional hormone therapy for menopause symptoms? the author notes:

“Some FDA-approved products come from plants. Examples include Estrace, Alora and other products that contain estrogens, and Prometrium, a natural progesterone”.20

In Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones) the JH include:

“Note that in Australia, doctors can prescribe menopausal hormone therapies (MHT) that are identical to those hormones made in your body. These products have been thoroughly tested for safety and effectiveness”.21

Health Care Provider

What if I choose to use bioidentical hormones?

If you choose to use bioidentical hormones it may be in your best interest to also choose to tell your health care providers you are doing this. The JH caution:

“Talk to qualified health practitioners about the risks and benefits of different treatments for menopause”.22

Health Topics A-Z

Where may I find Health Topics A-Z related to Bioidentical Hormones?

In Health Topics A-Z you may find:

Health Topics A-Z

Links

Where may I find Links related to Bioidentical Hormones?

Your Country may have Links similar to:

Links

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New or Updated

  1. Are Bioidentical Hormones Superior To Hormone Medications?
  2. BMS TV: Bioidentical Hormones
  3. BMS TV: Testosterone Explained
  4. Bioidentical HRT
  5. Bioidentical Hormones
  6. Bioidentical Hormones
  7. Bioidentical Hormones: Are They Safer? Are bioidentical or natural hormones safer and more effective than hormones used in traditional hormone therapy for menopause symptoms?
  8. Complementary & Alternative Therapies: Non-Hormonal Treatments for Menopause Symptoms
  9. Complementary Medicines and Therapies for Hot Flushes
  10. Complementary Medicines and Therapies: Options for Menopausal Symptoms
  11. Compounded Bioidentical Hormone Therapy
  12. Compounded Bioidentical Hormone Therapy [Video]
  13. Compounding and the FDA: Questions and Answers
  14. Consumer Video and Podcast Series: 2023 Consumer Videos and Podcasts – NAMS 2023 Nonhormone Therapies Position Statement for Bothersome Menopause Symptoms
  15. Consumer Video and Podcast Series: 2023 Consumer Videos and Podcasts – New FDA-Approved Nonhormone Option for the Treatment of Hot Flashes
  16. Consumer Video and Podcast Series: 2024 Consumer Videos and Podcasts – Preparing for Your Menopause Health Care Visit
  17. Deciding About Hormone Therapy
  18. Deciding About Hormone Therapy Use
  19. Emerging Research In the Management of Menopausal Symptoms
  20. Experts Answer Your Menopause Questions In New Video
  21. FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)
  22. FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)
  23. Fact or Fiction? The Role of Regulated Body-Identical Hormone Therapy for Menopausal Women
  24. Find A Menopause Practitioner [United States and Other]
  25. Find A Practitioner [Australasian Menopause Society i.e. Australia and New Zealand]
  26. Find Your Nearest BMS Menopause Specialist [British Menopause Society]
  27. Follicle-Stimulating Hormone (FSH) Levels Test
  28. HRT Questions Answered
  29. HRT: Summary
  30. Handling Hot Flushes and Night Sweats| Dr Louise Newson
  31. Herbal Remedies and Complementary Medicines for Menopause Symptoms: Bioidentical Hormones or “Natural” Hormones
  32. Hormone Replacement Therapy (HRT)
  33. Hormone Replacement Therapy (HRT): Alternatives To Hormone Replacement Therapy (HRT) – Herbal Remedies and Complementary Medicines for Menopause Symptoms: Bioidentical or “Natural” Hormones
  34. Hot Flashes
  35. Hot Flashes
  36. Hot Flashes: What Can I Do? [+ Video: What Are the Signs and Symptoms of Menopause?]
  37. How To Find Relief for Hot Flashes At Night
  38. International Menopause Society (IMS) Recommendations and Key Messages on Women’s Midlife Health and Menopause
  39. Is It Really ‘FDA Approved?’ FDA Doesn’t Approve Compounded Drugs
  40. Joint Position Statement by the British Menopause Society, Royal College of Obstetricians and Gynaecologists and Society for Endocrinology on Best Practice Recommendations for the Care of Women Experiencing the Menopause
  41. Later Years (Around 50 Years and Over): Menopause and Post Menopause Health – Hormone Replacement Therapy (HRT) [+ Video: Is HRT Bad for You?]
  42. Later Years (Around 50 Years and Over): Menopause and Post Menopause Health – Signs and Symptoms of Menopause [+ Video: Talking Menopause With Your GP]
  43. Looking At HRT In Perspective
  44. Luteinizing Hormone (LH) Levels Test
  45. Menopause
  46. Menopause
  47. Menopause Map: Downloadable Resources – My Personal Path Print Tools: Questions for Your Health Care Provider
    Bioidentical Hormones
  48. Menopause Map: Downloadable Resources – My Personal Path Print Tools: Symptom Tracker
  49. Menopause Symptoms and Relief
  50. Menopause Symptoms: Mayo Clinic Expert Outlines Hormone and Nonhormonal Therapies
  51. Menopause Treatment: Bioidentical Hormones
  52. Menopause Treatments: What Works, What Doesn’t
  53. Menopause: Diagnosis & Treatment
  54. Menopause: Identification and Management [NICE Guideline Published: 12 November 2015 Last Updated: 07 November 2024]
    Bioidentical Hormone Therapy
  55. Menopause: Identification and Management: NICE Guideline [NG23] [07 November 2024]
  56. National Academies of Science, Engineering, and Medicine (NASEM) Study on the Clinical Utility of Treating Patients With Compounded “Bioidentical” Hormone Therapy
  57. National Center for Complementary and Integrative Health: Herbs At A Glance
  58. National Center for Complementary and Integrative Health: How Safe Is This Product or Practice?
  59. National Center for Complementary and Integrative Health: Natural Doesn’t Necessarily Mean Safer, or Better
  60. National Women’s Health Week [11-17 May 2025]: Navigating the Road To Menopause
    Bioidentical Hormones
  61. Natural Remedies To Help Manage Perimenopause Symptoms
  62. Nonhormone Treatments for Hot Flashes and Night Sweats
  63. Office of Dietary Supplements: Black Cohosh
  64. Office of Dietary Supplements: Dietary Supplement Fact Sheets
  65. Safety and Efficacy of Compounded Bioidentical Hormone Therapy (cBHT) In Perimenopausal and Postmenopausal Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
  66. Shedding Light on the Menopause Experience and Demystifying Treatment
  67. The 2022 Hormone Therapy Position Statement of The North American Menopause Society
  68. The 2023 Practitioner’s Toolkit for Managing Menopause
  69. The Menopause Society Statement on Misinformation Surrounding Hormone Therapy
  70. The South African Menopause Society (SAMS) Statement on Compounded (Bioidentical) Menopausal Hormone Therapy
  71. Tips To Help Manage Menopause Symptoms
  72. Treatments for Menopause
  73. Vaginal Dryness Alternative Treatments
  74. Video & Podcast Library: Videos – World Menopause Day 2024: Menopause and Hormone Therapy: Current Perspectives and Controversies
  75. Videos and Podcasts: Videos – A Simple Approach To Menopause: The Menopause Quick Six (www.MQ6.ca)
  76. Webinars: Non-Hormonal Pharmacological Interventions For VMS
  77. Webinars: Symposia – What’s Hot? Options for Treatment of Hot Flushes 2025
  78. World Menopause Day 2024: Leaflet for Women – Menopause and Menopause Hormone Therapy [Multiply Languages]
  79. Bioidentical HormonesWorld Menopause Day 2024: Poster for Women

Sources

Where may I find the Sources quoted?

You may find the Sources quoted at:

Sources

  1. Menopause and Menopause Hormone Therapy: 2. What Is MHT? 2024:4. International Menopause Society https://www.imsociety.org/wp-content/uploads/2024/10/2024-WMD-Leaflet_English.pdf Accessed: 17 August 2025
  2. Menopausal Hormone Therapy. 2022:1. European Menopause and Andropause Society https://emas-online.org/wp-content/uploads/2022/05/Menopausal-hormone-therapy.pdf Accessed: 17 August 2025
  3. Burnett, T. Bioidentical Hormones: Are They Safer? 03 October 2024. https://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460 Accessed: 17 August 2025
  4. The 2022 Hormone Therapy Position Statement of The North American Menopause Society. July 2022:771. North American Menopause Society https://menopause.org/wp-content/uploads/professional/nams-2022-hormone-therapy-position-statement.pdf Accessed: 17 August 2025
  5. The 2022 Hormone Therapy Position Statement of The North American Menopause Society. July 2022:771. North American Menopause Society https://menopause.org/wp-content/uploads/professional/nams-2022-hormone-therapy-position-statement.pdf Accessed: 17 August 2025
  6. Bioidentical HRT: Summary of Key Terminologies. Reviewed: March 2024. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 17 August 2025
  7. Bioidentical HRT: Summary of Key Terminologies. Reviewed: March 2024. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 17 August 2025
  8. Compounding and the FDA: Questions and Answers – What Is Compounding? Content Current As of: 15 November 2024. Food and Drug Administration https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm339764.htm Accessed: 17 August 2025
  9. Burnett, T. Bioidentical Hormones: Are They Safer? 03 October 2024. https://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460 Accessed: 17 August 2025
  10. Treatments for Menopause: Menopausal Hormone Therapy (MHT) – What Are Bioidentical Hormones? Last Updated: 13 May 2025 | Last Reviewed: 22 April 2025. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 17 August 2025
  11. Bioidentical Hormones: Risks and Benefits – What Are the Risks of Bioidentical Hormones? 15 May 2022. Cleveland Clinic https://my.clevelandclinic.org/health/articles/15660-bioidentical-hormones Accessed: 17 August 2025
  12. The 2022 Hormone Therapy Position Statement of The North American Menopause Society. July 2022:771. North American Menopause Society https://menopause.org/wp-content/uploads/professional/nams-2022-hormone-therapy-position-statement.pdf Accessed: 17 August 2025
  13. Menopause and Menopause Hormone Therapy: 2. What Is MHT? 2024:4. International Menopause Society https://www.imsociety.org/wp-content/uploads/2024/10/2024-WMD-Leaflet_English.pdf Accessed: 17 August 2025
  14. Treatments for Menopause: Menopausal Hormone Therapy (MHT) – What Are Bioidentical Hormones? Last Updated: 13 May 2025 | Last Reviewed: 22 April 2025. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 17 August 2025
  15. Bioidentical HRT: Summary of Key Terminologies. Reviewed: March 2024. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 17 August 2025
  16. Davis, S. R., Taylor, S., Hemachandra, C., Magraith, K., Ebeling, P. R., Jane, F., and Islam, R. M. The 2023 Practitioner’s Toolkit for Managing Menopause: Management – Considerations for All Women At Menopause: Menopausal Hormone Therapy. Published Online: 30 October 2023 https://www.tandfonline.com/doi/full/10.1080/13697137.2023.2258783 Accessed: 17 August 2025
  17. Hormone Replacement Therapy (HRT): Alternatives To Hormone Replacement Therapy (HRT) – Herbal Remedies and Complementary Medicines for Menopause Symptoms: Bioidentical or “Natural” Hormones. Last Reviewed: 07 February 2023. NHS https://www.nhs.uk/medicines/hormone-replacement-therapy-hrt/alternatives-to-hormone-replacement-therapy-hrt/herbal-remedies-and-complementary-medicines-for-menopause-symptoms/ Accessed: 17 August 2025
  18. Hamoda, H., Mukherjee, A., Morris, E., Baldeweg, S. E., Jayasena, C. N., Briggs, P., Moger, S. Joint Position Statement By the British Menopause Society, Royal College of Obstetricians and Gynaecologists and Society for Endocrinology on Best Practice Recommendations for the Care of Women Experiencing the Menopause. First Published Online 10 June 2022:3-4. https://journals.sagepub.com/doi/full/10.1177/20533691221104879 Accessed: 17 August 2025
  19. Hormone Replacement Therapy (HRT): Alternatives To Hormone Replacement Therapy (HRT) – Herbal Remedies and Complementary Medicines for Menopause Symptoms: Bioidentical or “Natural” Hormones. Last Reviewed: 07 February 2023. NHS https://www.nhs.uk/medicines/hormone-replacement-therapy-hrt/alternatives-to-hormone-replacement-therapy-hrt/herbal-remedies-and-complementary-medicines-for-menopause-symptoms/ Accessed: 17 August 2025
  20. Burnett, T. Bioidentical Hormones: Are They Safer? 03 October 2024. https://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460 Accessed: 17 August 2025
  21. Treatments for Menopause: Menopausal Hormone Therapy (MHT) – What Are Bioidentical Hormones? Last Updated: 13 May 2025 | Last Reviewed: 22 April 2025. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 17 August 2025
  22. Treatments for Menopause: Menopausal Hormone Therapy (MHT) – What Are Bioidentical Hormones? Last Updated: 13 May 2025 | Last Reviewed: 22 April 2025. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 17 August 2025
Topic Last Updated: 17 August 2025 – Topic Last Reviewed: 17 August 2025

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