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Growth hormone axis · Evidence tier A · #5 in test requests

Tesamorelin

Egrifta · Egrifta SV · Egrifta WR · TH9507 · tesamorelin acetate · Tesa (vendor shorthand, e.g. ‘Tesa-10mg’)

Tesamorelin boosts growth hormone and is FDA-approved only for excess belly fat in adults with HIV13. Other uses have little evidence67, and vials sold online often fail tests2.

Illustration: a glass vial with a pink label reading Tesamorelin
Illustration, not a real product: an empty glass vial (photo: Missouri Historical Society, public domain) with our label. See every vial.

Quick answers

What is it?
A lab-made version of the brain hormone that triggers growth hormone release3. Its only approved use, as Egrifta, is cutting excess belly fat in adults with HIV13. Online sellers also offer it labeled “research use only”923.
Does it work?
Yes, for belly fat in HIV. In two large trials, deep belly fat fell about 15% more than on placebo over 26 weeks4519. Weight did not change, and the fat returned after stopping34. Lean mass rose a little3638; we found no completed muscle-building trial394041.
Is it safe?
It has known risks. In trials a growth factor rose above normal in 47% of treated patients, and well above in 36%; that may raise cancer risk316. It can raise blood sugar and cause joint pain and swelling3. Long-term heart safety is not established13.
Is it legal?
Yes, with a prescription, as Egrifta1. US pharmacies may not make it, by our reading of FDA rules815. In August 2026, FDA warned online sellers that “research” tesamorelin is an unapproved drug923. Banned in sport at all times1031.
What is in the vials?
More than 4 in 10 failed testing: 83 of the 191 completed tests among Finnrick’s latest 200, from May to September 20262. People choose which samples to send, so this is not a random survey2.

What it is

Tesamorelin is a synthetic version of growth-hormone-releasing hormone (GHRH), the hormone the brain uses to tell the pituitary gland to release growth hormone (GH). It keeps all 44 amino acids of human GHRH and adds a short fatty chain (a hexenoyl group) to the first one3. That change makes it more stable than natural GHRH1112. In lab tests it activates the GHRH receptor about as strongly as the natural hormone13. It raises the body’s own GH output, which then raises IGF-1, a growth factor made in the liver and other tissues13. Because it works upstream of GH, the body’s own control loops, such as IGF-1 feedback, still shape the response12. In healthy men it increased both background and pulsed GH release7. Those controls do not keep IGF-1 normal, though: after 26 weeks, 47% of trial patients had IGF-1 more than 2 standard deviations above the normal average3.

Theratechnologies, a Montreal company, developed tesamorelin under the code TH950735. The FDA approved it as Egrifta on 10 November 201013. Newer versions, Egrifta SV and Egrifta WR (label revised March 2025), use lower doses that give blood levels comparable to the original 2 mg dose13. Because it is longer than 40 amino acids, US law treats it as a protein, and its approval became a biologics license on 23 March 20201415. In Europe, Ferrer withdrew its application in 201216. On 25 September 2025 Theratechnologies announced that an affiliate of Future Pak, a privately held Michigan contract manufacturer, packager and distributor of drugs and supplements, had completed its purchase of the company17.

Benefits: what the research shows

The best evidence comes from two Phase 3 placebo-controlled trials in adults with HIV and excess belly fat, with 412 and 404 people419. Daily 2 mg for 26 weeks cut visceral fat by 15.2% (versus a 5.0% rise on placebo) in the first trial and by 10.9% (versus a 0.6% fall) in the second419. A pooled analysis of 806 of these people found a treatment effect of −15.4% versus placebo5. The label counts everyone randomized and carries forward the last measurement of the 20% to 26% who stopped early3. On that basis visceral fat fell 18% and 14%, against a 2% rise and a 2% fall on placebo3. Triglycerides fell, IGF-1 rose, and weight did not change319. The benefit held at 52 weeks in people who kept injecting and was quickly lost in those switched to placebo4. Smaller trials in people with HIV also found less liver fat, including a 37% relative drop over 12 months in 61 people with fatty liver2021. European regulators doubted that the fat loss brings real health benefits16. At approval in 2010, FDA required a safety study of at least 10 years and a placebo-controlled trial of diabetic eye disease that would also review heart events45. The maker’s registry records list both as terminated, ending in August 2018, with no results posted4647. We found no trial that tested whether tesamorelin prevents heart attacks or deaths4042. Outside HIV the data are small. In 53 people with type 2 diabetes, 12 weeks at 1 or 2 mg did not worsen blood sugar control11. In 152 adults aged 55 to 87, some healthy and some with mild memory problems, 1 mg nightly for 20 weeks gave a modest gain on thinking tests (P=.03), lowered percent body fat by 7.4% and raised lean muscle mass by 3.7%6. A 2025 open-label trial in 73 people with HIV found no clear thinking benefit over usual care; its authors note it lacked statistical power and a placebo group22. In 13 healthy men, 2 mg daily for 2 weeks raised overnight GH and IGF-1 with no significant change in insulin sensitivity7. In a 12-month placebo-controlled trial in 60 adults with obesity and low growth hormone output, lean mass rose 1.4 kg more on tesamorelin than on placebo, though the authors say some of that gain may be water38. We found no completed trial designed to test tesamorelin for muscle building, athletic performance or recovery394041.

Key human studies

StudyDesignPeopleDose and routeResult
Falutz et al., N Engl J Med 200719PubMed · DOI · NCT00123253 Phase 3 randomized, double-blind, placebo-controlled trial, 26 weeks; HIV with abdominal fat accumulation 412 2 mg subcutaneous once daily Visceral fat -15.2% vs +5.0% on placebo; triglycerides -50 vs +9 mg/dL; IGF-1 +81%; no difference in glucose measures; more withdrawals for adverse events on tesamorelin19.
Falutz et al., J Acquir Immune Defic Syndr 20104PubMed · DOI Second Phase 3 randomized (2:1), double-blind, placebo-controlled trial, 26 weeks, plus a 26-week blinded extension with re-randomization 404 2 mg subcutaneous once daily Visceral fat -10.9% vs -0.6% at 26 weeks; about -18% after 12 months of continued use; gains were rapidly lost after switching to placebo; no change in glucose measures4.
Stanley et al., Lancet HIV 201921PubMed · DOI · NCT02196831 Randomized, double-blind, placebo-controlled trial, 12 months; HIV with fatty liver (liver fat 5% or more) 61 2 mg subcutaneous once daily Liver fat fraction -4.1 percentage points vs placebo (-37% relative); 35% vs 4% reached liver fat below 5%; changes in fasting glucose and HbA1c did not differ21.
Clemmons et al., PLoS One 201711PubMed · DOI · NCT01264497 Randomized, placebo-controlled trial, 12 weeks; type 2 diabetes 53 1 mg or 2 mg subcutaneous once daily No change in insulin response, fasting glucose or HbA1c vs placebo; total and non-HDL cholesterol fell about 0.3 mmol/L at 2 mg11.
Baker et al., Arch Neurol 20126PubMed · DOI · NCT00257712 Randomized, double-blind, placebo-controlled trial, 20 weeks; healthy older adults and adults with mild cognitive impairment (age 55 to 87) 152 1 mg subcutaneous nightly Small favorable effect on a cognitive composite (P=.03 in the intention-to-treat analysis), mainly executive function; IGF-1 +117%; percent body fat -7.4%; lean muscle mass +3.7%; mild adverse events in 68% vs 36% on placebo6.
Stanley et al., J Clin Endocrinol Metab 20117PubMed · DOI · NCT00850564 Uncontrolled before-and-after study: 2 weeks on treatment, then 2 weeks off; healthy men 13 2 mg subcutaneous once daily Mean overnight GH, GH pulse area and background GH secretion rose; IGF-1 rose by 181 µg/L; fasting glucose and insulin-stimulated glucose uptake did not change significantly7.

Doses studied

Doses below are what studies used or what a label says. They are not advice, and gray-market products may not contain what their label says.

In human studies

Approved doses: Egrifta SV 1.4 mg or Egrifta WR 1.28 mg injected under the skin of the abdomen once daily. Both give blood levels comparable to the original product’s 2 mg once daily1333. The Phase 3 trials used 2 mg once daily for 26 to 52 weeks419. Other trials used 2 mg daily for 6 to 12 months (liver fat in HIV; belly fat in obesity without HIV), 1 or 2 mg daily for 12 weeks (type 2 diabetes), 1 mg nightly for 20 weeks (older adults) and 2 mg daily for 2 weeks (healthy men)6711202138. A trial in COPD that assigned people to 2 or 3 mg daily was stopped by its sponsor, for a reason unrelated to safety, after 2 people had started39. We found no completed trial that tested a higher dose, on-off cycles or blends with other peptides3940.

In animal studies

Not applicable or not reported.

What users report Anecdotal · not validated · not a recommendation

A bodybuilding-oriented source compiled in a 2026 medical review describes 2 mg under the skin once a day, used for body composition rather than for HIV lipodystrophy12.

Half-life
About 11 minutes (Egrifta WR)3Mean elimination half-life in healthy adults after one under-the-skin dose of 1.28 mg Egrifta WR. The Egrifta SV label gives 8 minutes after 1.4 mg. The original 2010 label gave 26 minutes in healthy people and 38 minutes in people with HIV after 14 daily 2 mg doses. Less than 4% of an injected dose reaches the bloodstream.
Routes
  • Subcutaneous injection (the approved route; all human data)

Every dose studied for Tesamorelin, with sources →

Quality and the gray market

What testing finds

Finnrick, a service that publishes lab results for peptide samples, lists 706 tesamorelin tests from 106 vendors (7 May 2025 to 24 September 2026). Of the 200 most recent (5 May 2026 to 24 September 2026), 108 passed, 83 failed and 9 were incomplete: a 43% fail rate among completed tests. Its default pass mark is purity of at least 99.5% with the measured amount within 35% of the label2. The public page does not say why each sample failed, and samples are chosen by the people who send them, so this is not a random survey. We found no published purity study of gray-market tesamorelin43.

How it is sold

Sold online as ‘research use only’ powder, for example in 10 mg vials, and in blends with ipamorelin. One seller called a 10 mg tesamorelin plus 3 mg ipamorelin blend ‘BIMORELIN’9. On 30 September 2026 it appeared on vendor best-seller and popularity-sorted lists, including as ‘Tesa-10mg’ at $79.993435. By our count of the monthly figures on Finnrick’s request-data page, tesamorelin drew 1,329 of 21,253 test requests (6.3%) from May 2025 to May 2026, the fifth most of any product; the page gives the total as about 21,27536. Its monthly requests rose from 56 in June 2025 to a peak of 186 in March 2026, and were 169 in May 202636. A 2026 medical review names it among the GH-axis peptides most often seen in clinical practice and online self-use protocols12. Brand-name Egrifta requires a prescription in the US1.

Side effects and risks

  • High IGF-1: after 26 weeks, 47% of trial patients had IGF-1 above 2 SD and 36% above 3 SD. The long-term effects are unknown, and European reviewers called this a major safety concern because high IGF-1 may raise cancer risk and worsen diabetic eye disease316.
  • Cancer: GH is a known growth factor, and the labels list active cancer as a reason not to use it3.
  • Blood sugar: 5% of treated patients vs 1% on placebo reached diabetes-range HbA1c (6.5% or more); the labels call for checking glucose before and during treatment3.
  • Fluid retention and aches: joint pain (13.3% vs 11.0%), muscle pain (5.5% vs 1.9%), swelling of the limbs (6.1% vs 2.3%) and tingling (4.8% vs 2.3%) in the first 26 weeks; carpal tunnel syndrome can occur333.
  • Injection-site reactions (25% vs 14%) and allergic reactions such as itching, flushing, hives and rash (4%)3.
  • Antibodies: about half of patients made anti-tesamorelin antibodies, and about 60% of those cross-reacted with the body’s own GHRH3.
  • Contraindicated in pregnancy and with pituitary disease or damage; the GH class carries a warning of higher death rates in acutely critically ill patients3.
  • Gray-market products: unknown identity, dose and sterility, with frequent test failures; athletes risk an anti-doping violation210.

Documented harms

  • 30 Jul 2026FDA’s adverse event database (FAERS, via openFDA, data updated 30 July 2026) holds 1,586 reports that list tesamorelin, received from 2013 to June 2026; 324 are coded serious. The most frequent terms are missed or incorrect doses (285 and 164 reports), injection-site pain (141), drug ineffective (128), product preparation issues (121), weight increased (97) and joint pain (95). Reports are unverified, mostly involve the prescription product, and do not prove the drug caused the event37.

Questions people ask

Is tesamorelin FDA approved?

Yes, but only for excess abdominal fat in adults with HIV-associated lipodystrophy; the current labels are for Egrifta SV and Egrifta WR1313. It is not approved for weight loss, bodybuilding or anti-aging, and FDA treats ‘research’ tesamorelin sold online as an unapproved drug9.

Does tesamorelin work for fat loss if you don’t have HIV?

A placebo-controlled trial tested it in 60 adults aged 18 to 55 with obesity and low growth hormone output: over 12 months, deep belly fat fell 16 cm² on 2 mg daily and rose 19 cm² on placebo, and fat under the skin did not change significantly38. In a 20-week trial in older adults, 1 mg nightly lowered percent body fat by 7.4%, but the trial was designed to test thinking, not fat loss6. In people with HIV it reduced deep belly fat but not body weight, and the fat came back after stopping34.

Can a compounding pharmacy make tesamorelin?

FDA says biologics cannot be compounded under 503A or 503B, and Egrifta is regulated as a biologic815. So we know of no lawful route for compounded tesamorelin.

Is tesamorelin banned in sports?

Yes. WADA names tesamorelin under S2.2.4 (GHRH analogues), prohibited in and out of competition, in both the 2026 and 2027 Lists1031.

What are the side effects of tesamorelin?

In trials the most common were joint pain, injection-site redness and itching, limb pain, swelling and muscle pain3. It can also raise IGF-1 and blood sugar, and about half of users develop antibodies3.

What is still unknown

  • Long-term heart and cancer safety of months or years of raised IGF-1 is not established (a label limitation), and we could not confirm FDA’s current status for the long-term safety studies it required in 2010.
  • Whether cutting visceral fat improves health outcomes such as heart attacks or survival. We found no trial that tested this.
  • We found little data in healthy adults on muscle, performance or long-term body composition, and none on on-off cycles or blends with ipamorelin or CJC-1295.
  • Why gray-market tesamorelin samples fail Finnrick tests (low purity, wrong amount or wrong compound) is not public.
  • Registry conflict: the Egrifta label assigns NCT00435136 to Phase 3 Study 2, but ClinicalTrials.gov lists NCT00435136 as an alias of Study 1 (NCT00123253); we left the Study 2 NCT blank.
  • Canada: whether any tesamorelin product is marketed now was not confirmed beyond the canceled Egrifta listing. Australia: whether the GHRH group entry covers tesamorelin was not confirmed. UK status not verified.
  • Ongoing Phase 2 trials: NCT03150511 (nerve injury repair, Johns Hopkins, recruiting, planned completion December 2027) and NCT06554717 (exercise and physical function in HIV, Massachusetts General Hospital, recruiting, planned completion December 2028).

Sources

  1. 1EGRIFTA SV (tesamorelin) for injection: prescribing information (revised 2/2024) Theratechnologies via DailyMed (U.S. National Library of Medicine), Feb 2024. dailymed.nlm.nih.gov
  2. 2Tesamorelin: safety testing results and vendor ratings Finnrick, 24 Sep 2026. finnrick.com
  3. 3EGRIFTA WR (tesamorelin) for injection: prescribing information (revised 3/2025) Theratechnologies via DailyMed (U.S. National Library of Medicine), Mar 2025. dailymed.nlm.nih.gov
  4. 4Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension Journal of Acquired Immune Deficiency Syndromes, Mar 2010. pubmed.ncbi.nlm.nih.gov
  5. 5Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data The Journal of Clinical Endocrinology & Metabolism, Sep 2010. pubmed.ncbi.nlm.nih.gov
  6. 6Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial Archives of Neurology, Nov 2012. pubmed.ncbi.nlm.nih.gov
  7. 7Effects of a growth hormone-releasing hormone analog on endogenous GH pulsatility and insulin sensitivity in healthy men The Journal of Clinical Endocrinology & Metabolism, Jan 2011. pubmed.ncbi.nlm.nih.gov
  8. 8Compounding and the FDA: Questions and Answers U.S. Food and Drug Administration, 16 Sep 2025. fda.gov
  9. 9Warning letter to Royal Peptides LLC (MARCS-CMS 734884) U.S. Food and Drug Administration, 24 Aug 2026. fda.gov
  10. 10World Anti-Doping Code International Standard: Prohibited List 2026 World Anti-Doping Agency, 24 Sep 2025. wada-ama.org
  11. 11Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: a randomized, placebo-controlled trial PLoS One, 2017. pubmed.ncbi.nlm.nih.gov
  12. 12The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration Frontiers in Endocrinology, 18 Jun 2026. frontiersin.org
  13. 13Drugs@FDA: BLA 022505, Egrifta (tesamorelin acetate) U.S. Food and Drug Administration (Drugs@FDA), accessed 8 Oct 2026. accessdata.fda.gov
  14. 14Definition of the Term “Biological Product” (final rule, 85 FR 10057) Federal Register, 21 Feb 2020. federalregister.gov
  15. 15List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020 U.S. Food and Drug Administration, accessed 1 Oct 2026. fda.gov
  16. 16Egrifta: withdrawal of the marketing authorisation application (questions and answers, EMA/CHMP/475021/2012) European Medicines Agency, 18 Jul 2012. ema.europa.eu
  17. 17Theratechnologies Announces Completion of Acquisition by Future Pak Theratechnologies Inc., 25 Sep 2025. theratech.com
  18. 18Tesamorelin, PubChem compound summary (CID 16137828) PubChem, U.S. National Library of Medicine, accessed 1 Oct 2026. pubchem.ncbi.nlm.nih.gov
  19. 19Metabolic effects of a growth hormone-releasing factor in patients with HIV New England Journal of Medicine, 6 Dec 2007. pubmed.ncbi.nlm.nih.gov
  20. 20Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial JAMA, 23 Jul 2014. pubmed.ncbi.nlm.nih.gov
  21. 21Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial The Lancet HIV, Dec 2019. pubmed.ncbi.nlm.nih.gov
  22. 22Effects of tesamorelin on neurocognitive impairment in persons with HIV and abdominal obesity Journal of Infectious Diseases, 2 Jun 2025. pubmed.ncbi.nlm.nih.gov
  23. 23Warning letter to NuScience Peptides LLC (MARCS-CMS 733652) U.S. Food and Drug Administration, 24 Aug 2026. fda.gov
  24. 2421 CFR Part 1308, Schedules of Controlled Substances (eCFR, as of 25 September 2026) Electronic Code of Federal Regulations (eCFR), 25 Sep 2026. ecfr.gov
  25. 25Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories list) U.S. Food and Drug Administration, 14 May 2026. fda.gov
  26. 26Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act (categories list) U.S. Food and Drug Administration, 21 Mar 2025. fda.gov
  27. 27Drug Product Database: EGRIFTA (DIN 02438712) product record Health Canada, 30 Sep 2022. health-products.canada.ca
  28. 28Prescription Drug List: Human Use Health Canada (Drug and Health Product Register), accessed 30 Sep 2026. hpr-rps.hres.ca
  29. 29Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks (RA-77807) Health Canada, 1 Aug 2025. recalls-rappels.canada.ca
  30. 30Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026 (F2026L01327) Federal Register of Legislation, Australian Government, 28 Sep 2026. legislation.gov.au
  31. 31World Anti-Doping Code International Standard: Prohibited List 2027 World Anti-Doping Agency, 21 Sep 2026. wada-ama.org
  32. 32Triathlon Athlete Accepts Sanction for Anti-Doping Rule Violations U.S. Anti-Doping Agency, 17 Sep 2025. usada.org
  33. 33EGRIFTA (tesamorelin for injection) prescribing information, original 2010 label U.S. Food and Drug Administration (Drugs@FDA), Nov 2010. accessdata.fda.gov
  34. 34Orbitrex homepage, ‘Best-selling research peptides’ list Orbitrex (vendor), accessed 30 Sep 2026. orbitrex.com (seller page, deliberately not linked)
  35. 35Ascension Peptides shop page sorted by popularity Ascension Peptides (vendor), accessed 30 Sep 2026. ascensionpeptides.com (seller page, deliberately not linked)
  36. 36We’d Rather Buy the Future Than Wait For It Finnrick, 10 Jun 2026. finnrick.com
  37. 37FDA Adverse Event Reporting System (FAERS) reports listing tesamorelin, counted via the openFDA drug/event API U.S. Food and Drug Administration (openFDA), 30 Jul 2026. api.fda.gov · data query
  38. 38Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trial The Journal of Clinical Endocrinology & Metabolism, Dec 2012. pubmed.ncbi.nlm.nih.gov
  39. 39Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting (NCT01388920) ClinicalTrials.gov, 18 Mar 2022. clinicaltrials.gov
  40. 40ClinicalTrials.gov search: tesamorelin (24 studies) ClinicalTrials.gov, accessed 8 Oct 2026. clinicaltrials.gov
  41. 41PubMed search: tesamorelin with muscle, lean mass, strength, athletes, physical or exercise performance, recovery, sarcopenia or frailty (29 results) National Library of Medicine (PubMed), accessed 8 Oct 2026. pubmed.ncbi.nlm.nih.gov
  42. 42PubMed search: tesamorelin with cardiovascular events, myocardial infarction, mortality, stroke or heart attack (10 results) National Library of Medicine (PubMed), accessed 8 Oct 2026. pubmed.ncbi.nlm.nih.gov
  43. 43PubMed search: tesamorelin with purity, counterfeit, adulteration, research use, gray, grey or black market, internet, online or illicit (6 results) National Library of Medicine (PubMed), accessed 8 Oct 2026. pubmed.ncbi.nlm.nih.gov
  44. 44Unauthorized health products sold online and seized at Rize Fitness may pose serious health risks (RA-81403) Health Canada, 24 Dec 2025. recalls-rappels.canada.ca
  45. 45Approval letter for NDA 022505, Egrifta (tesamorelin for injection) U.S. Food and Drug Administration, 10 Nov 2010. accessdata.fda.gov
  46. 46Long-term Observational Study in HIV Subjects Exposed to EGRIFTA® (NCT01579695) ClinicalTrials.gov, 11 Sep 2018. clinicaltrials.gov
  47. 47Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA® (NCT01591902) ClinicalTrials.gov, 11 Sep 2018. clinicaltrials.gov
  48. 48Warning letter to Peak Performance Peptides (MARCS-CMS 735127) U.S. Food and Drug Administration, 24 Aug 2026. fda.gov
  49. 49Warning letter to Peptide Partners LLC (MARCS-CMS 735063) U.S. Food and Drug Administration, 24 Aug 2026. fda.gov
  50. 50Warning letter to TXP Innovations LLC dba Tex Peptides (MARCS-CMS 735067) U.S. Food and Drug Administration, 24 Aug 2026. fda.gov

Not medical advice. This page reports what studies and regulators say; it does not recommend using any product. How we grade evidence · Report an error.