Whole leaf Aloe Vera concentrate • Purified Water • Squalene • Emu Oil • Glyceryl Stearate • Lanolin Alcohol • Propylene Glycol • Sorbitan Sesquioleate • Stearic Acid • Dimethicone • PEG-75 Lanolin • Allantoin • Polysorbate-60 • Peach Kernel Oil • Apricot Kernel oil • Sesame Seed Oil • Jojoba oil • Carbomer-940 • Triethanolamine • Methylparaben • Fragrance • Imidazolidinyl Urea • Propylparaben.
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Below is general information about the effectiveness of the known ingredients contained in the product Body Lotion with Emu Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Body Lotion with Emu Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when aloe gel is used topically and appropriately. Aloe gel-containing formulations have been safely applied in clinical trials (101,11982,12096,12098,12159,12160,12163,12164,17418)(90123,90124,90127,90128,90129,90131,97320,98816,103305). When included in topical cosmetics, the Cosmetic Ingredient Review Expert Panel concluded that aloe-derived anthraquinone levels should not exceed 50 ppm (90122).
POSSIBLY SAFE ...when aloe gel is used orally and appropriately, short-term. Aloe gel has been safely used in a dose of 15 mL daily for up to 42 days or 100 mL of a 50% solution twice daily for up to 4 weeks (11984,12164). Also, a specific aloe gel complex (Aloe QDM complex, Univera Inc.) has been safely used at a dose of approximately 600 mg daily for up to 8 weeks (90121). ...when aloe extract is used orally and appropriately, short-term. Aloe extract has been used with apparent safety in a dose of 500 mg daily for one month (101579). Also, an aloe extract enriched in aloe sterols has been used with apparent safety in a dose of 500 mg daily for 12 weeks (101577).
POSSIBLY UNSAFE ...when aloe latex is used orally. There is some evidence that anthraquinones in aloe latex are carcinogenic or promote tumor growth, although data are conflicting (6138,16387,16388,91596,91597). In 2002, the US FDA banned the use of aloe latex in laxative products due to the lack of safety data (8229). ...when aloe whole-leaf extract is used orally. Aloe whole-leaf extract that has not been filtered over charcoal still contains anthraquinones. This type of aloe whole-leaf extract is referred to as being "nondecolorized". The International Agency for Research on Cancer has classified this type of aloe whole-leaf extract as a possible human carcinogen (91598,91908). Although filtering aloe whole-leaf extract over charcoal removes the anthraquinones, some animal research suggests that this filtered extract, which is referred to as being "decolorized", may still cause gene mutations (91598). This suggests that constituents besides anthraquinones may be responsible for the carcinogenicity of aloe whole-leaf extract. It should be noted that commercial products that contain aloe whole-leaf extract may be labeled as containing "whole leaf Aloe vera juice" or "aloe juice" (91908).
LIKELY UNSAFE ...when aloe latex is used orally in high doses. Ingesting aloe latex 1 gram daily for several days can cause nephritis, acute kidney failure, and death (8,8961).
CHILDREN: POSSIBLY SAFE
when aloe gel is used topically and appropriately.
Aloe gel-containing formulations have been safely applied in clinical trials (90124,90131).
CHILDREN: POSSIBLY UNSAFE
when aloe latex and aloe whole leaf extracts are used orally in children.
Children younger than 12 years may experience abdominal pain, cramps, and diarrhea (4).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Anthraquinones present in aloe latex and aloe whole leaf extracts have irritant, cathartic, and possible mutagenic effects (4,16387,16388,90122). There are also anecdotal reports and evidence from animal research that anthraquinones or aloe whole leaf extracts might induce abortion and stimulate menstruation; avoid using (4,8,19,90122).
LACTATION: POSSIBLY UNSAFE
when aloe preparations are used orally.
Cathartic and mutagenic anthraquinones present in aloe latex and aloe whole leaf extracts might pass into milk; avoid using (4,19).
LIKELY SAFE ...when purified apricot kernel oil is used orally in food amounts. Purified apricot kernel oil has Generally Recognized as Safe (GRAS) status in the US (4912,105943). ...when purified apricot kernel oil is applied topically (105943).
POSSIBLY SAFE ...when apricot kernel is used orally in the diet in small amounts. Consuming no more than 1-2 small kernels or half of a large kernel daily is considered safe by the European Food Safety Authority, the Food Safety Authority of Ireland, and Health Canada (105944,105945,105946).
LIKELY UNSAFE ...when apricot kernel is used orally in larger amounts. Apricot kernels provide approximately 0.5 mg cyanide per kernel, although exact cyanide content varies. The World Health Organization (WHO) and the European Food Safety Committee (EFSA) have set a tolerable daily intake of cyanide at 12 mcg/kg and 20 mcg/kg, respectively (105945,106501). To minimize the risk of cyanide toxicity, the EFSA, the Food Safety Authority of Ireland, and Health Canada recommend against consuming more than 2 small apricot kernels or more than half of a large apricot kernel daily (105944,105945,105946). There is insufficient reliable information available about the safety of using non-purified or virgin apricot kernel oil orally or topically. Partially processed apricot kernel oil may contain amygdalin and/or hydrogen cyanide in variable quantities (105943).
CHILDREN: LIKELY UNSAFE
when apricot kernel is used orally.
The European Food Safety Authority, the Food Safety Authority of Ireland, and Health Canada recommend against the use of apricot kernels in children. Consumption of only half of one small kernel can exceed safe levels in toddlers (105944,105945,105946).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when apricot kernels are taken orally.
The Hellenic Food Authority recommends that pregnant or breastfeeding patients avoid consumption of apricot kernels (4,12,105944,105945,105946).
LIKELY SAFE ...when used topically (6).
LIKELY UNSAFE ...when used orally because it contains 14% erucic acid, which can cause myocardial fibrosis (6); avoid using.
PREGNANCY AND LACTATION: LIKELY SAFE
when used topically for hygienic uses (6).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally (6).
LIKELY SAFE ...when used orally in amounts commonly found in food. Sesame has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when sesame oil is used orally and appropriately, short-term. Sesame oil has been used with apparent safety in doses up to 35 grams daily for up to 12 weeks (96179,96180,108354). The sesame constituent sesamin has been used with apparent safety at doses of 200 mg daily for 6 weeks (103230) and 10 mg daily for 12 weeks (99863). Sesame oil 150 mL has also been administered via nasogastric tube with apparent safety as a single dose (27645). ...when sesame oil is used in a nasal spray, short-term. A specific nasal spray (Nozoil) containing sesame oil has been used with apparent safety for up to 20 days (27658,27659,27660). ...when sesame oil is applied topically (96178,103227,103228). There is insufficient reliable information available about the safety of other forms of sesame when used in medicinal amounts.
CHILDREN: POSSIBLY SAFE
when sesame oil is used orally and appropriately in medicinal amounts, short-term.
Sesame oil 5 mL has been used safely at bedtime for up to 3 days (27647).
PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of sesame when used in medicinal amounts during pregnancy and lactation.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Shark liver oil 1.5 grams once daily has been used safely for 8 weeks (94286).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used topically and appropriately. Squalamine eye drops have been safely used twice daily for up to 38 weeks (96044). ...when used intravenously and appropriately. Squalamine has been safely used at a dose of up to 50 mg/m2 once weekly for up to 4 weeks, or 300 mg/m2 daily as a 5-day infusion once every 3 weeks for up to 6 cycles (96040,96042,96045). There is insufficient reliable information available about the safety of squalamine when used orally.
CHILDREN: POSSIBLY SAFE
when used topically and appropriately, short-term.
Squalamine 1% lotion has been safely applied to the scalp once daily for up to 3 weeks in children aged 6-15 years (96041).
PREGNANCY AND LACTATION:
Insufficient reliable information is available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Body Lotion with Emu Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, aloe gel might increase the risk of bleeding when taken with anticoagulant or antiplatelet drugs.
Details
In vitro research shows that aloe gel can inhibit platelet aggregation. This inhibition was greater than that seen with celecoxib, but less than that seen with aspirin (105501).
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Aloe might increase the risk of hypoglycemia when taken with antidiabetes drugs.
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Theoretically, aloe might decrease the levels and clinical effects of CYP1A2 substrates.
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In vitro research shows that aloe extract induces CYP1A2 enzymes (111404).
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Theoretically, aloe latex might increase the risk of adverse effects when taken with cardiac glycosides.
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Overuse of aloe latex can increase the risk of adverse effects from cardiac glycoside drugs, such as digoxin, due to potassium depletion. Overuse of aloe, along with cardiac glycoside drugs, can increase the risk of toxicity (19).
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Theoretically, aloe latex might increase the risk of hypokalemia when taken with diuretic drugs.
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Overuse of aloe latex might compound diuretic-induced potassium loss, increasing the risk of hypokalemia (19).
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Theoretically, aloe latex might increase the risk for fluid and electrolyte loss when taken with stimulant laxatives.
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Theoretically, aloe latex might increase the risk of bleeding when taken with warfarin.
Details
Aloe latex has stimulant laxative effects. In some people aloe latex can cause diarrhea. Diarrhea can increase the effects of warfarin, increase international normalized ratio (INR), and increase the risk of bleeding. Advise patients who take warfarin not to take excessive amounts of aloe vera.
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Taking sesame oil with antidiabetes drugs might increase the risk of hypoglycemia.
Details
Clinical studies show that sesame oil can decrease plasma glucose and glycated hemoglobin (HbA1c) levels. Some clinical research in patients taking glibenclamide shows that using sesame oil or a blend of sesame oil and rice bran oil in place of other oil for cooking reduces plasma glucose more than glibenclamide alone (27654,28139,96177,108350,108352,108355). Monitor blood glucose levels closely. Dose adjustments might be necessary.
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Taking sesame oil with antihypertensive drugs might increase the risk of hypotension.
Details
Clinical research shows that replacing other cooking oil with sesame oil can lower systolic blood pressure (SBP) and diastolic blood pressure (DBP) in patients with or without hypertension. There is also some evidence that sesame oil has additive effects in patients also taking atenolol, nifedipine, and/or hydrochlorothiazide (27652,27654,27655,96179,108355,108357). In patients using nifedipine, using a blend of sesame oil and rice bran oil for cooking reduces both SBP and DBP more than nifedipine alone (96180).
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Theoretically, sesame might increase the levels and clinical effects of CYP2C9 substrates.
Details
In vitro, sesame inhibits CYP2C9 (11028). However, this interaction has not been reported in humans.
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Theoretically, sesame might alter the transport of P-glycoprotein substrates.
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Theoretically, sesame might interfere with tamoxifen.
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Below is general information about the adverse effects of the known ingredients contained in the product Body Lotion with Emu Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally and topically, aloe products are generally well tolerated when used in typical doses.
However, oral aloe latex is associated with a greater risk of adverse effects, especially when used in high doses or long-term.
Most Common Adverse Effects:
Orally: Aloe latex may cause abdominal pain, cramps, and diarrhea.
Topically: Burning, erythema, and itching. Contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Aloe latex is associated with serious adverse effects when taken in high doses or long-term. Cases of acute hepatitis due to a hypersensitivity reaction to aloe leaf extract has been reported.
Dermatologic ...Topically, aloe gel has occasionally been associated with burning (12164,19741,30697,30706), itching (12164,19741,30697), eczema (90122), erythema (19748,30706,90123), contact dermatitis (12163,12164,30695,30736,30737,30738,30740), popular eruption (30732), and urticaria (30712). Also, a case of generalized nummular and popular dermatitis attributed to hypersensitivity has been reported for a 47-year-old male who used aloe leaf gel, both topically and orally, for 4 years (30740).
Endocrine ...A case of severe hypokalemia has been reported for a male breast cancer patient who was undergoing chemotherapy and using aloe vera 1 liter daily orally for 2 weeks. The hypokalemia was attributed to the cathartic effects of aloe and resolved once aloe use was discontinued (30704).
Gastrointestinal
...Orally, aloe latex can cause abdominal pain and cramps.
Long-term use or abuse of aloe latex can cause diarrhea, sometimes with hypokalemia, albuminuria, hematuria, muscle weakness, weight loss, arrhythmia, and pseudomelanosis coli (pigment spots in intestinal mucosa). Pseudomelanosis coli is believed to be harmless, and usually reverses with discontinuation of aloe. It is not directly associated with an increased risk of developing colorectal adenoma or carcinoma (6138). Orally, aloe gel may cause nausea, stomach cramps, and other gastrointestinal complaints in some patients (104174,111921,111663).
Topically, applying aloe gel in the mouth may cause nausea within 5 minutes of application in some patients (90124).
Hematologic ...A case of Henoch-Schonlein purpura, characterized by abdominal pain, purpura, and severe arthralgia, has been reported in a 52-year-old male who drank aloe juice prepared from four to five leaflets for 10 days prior to symptom development (91598).
Hepatic ...Cases of acute hepatitis have been reported after ingestion of aloe leaf extracts for between 3 weeks and 5 years. This is thought to be a hypersensitivity reaction (15567,15569,16386,17419,90126,91598). A case of acute hepatitis has also been reported for a 45-year-old female who drank two ounces of Euforia juice (Nuverus International), a product containing green tea, noni, goji, and aloe, daily for one month (90125). However, one small clinical trial in healthy individuals shows that taking aloe gel 2 ounces twice daily for 60 days does not impair liver function (104174).
Renal ...Orally, aloe latex can cause hemorrhagic gastritis, nephritis, and acute kidney failure following prolonged use of high doses (1 gram daily or more) (8961).
General
...Orally, consuming more than 2 small apricot kernels or half of a large apricot kernel daily may precipitate acute or chronic cyanide toxicity in adults.
In children, apricot kernels can be toxic in any dose. Orally and topically, purified apricot kernel oil seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: Acute cyanide toxicity with large doses of apricot kernel. Chronic cyanide poisoning with long-term intake of apricot kernel.
Hepatic ...In one case report, a 58-year-old male receiving palliative chemotherapy developed elevated liver function enzymes without other signs of toxicity after consuming 70 chopped apricot kernels daily for 45 days. One week after discontinuing the use of apricot kernels, the patient still had a thiocyanate level of 71 mg/dL (94064).
Other
...Apricot kernel contains amygdalin, which is converted to cyanide in the body and can cause cyanide poisoning.
Signs of acute cyanide poisoning include abdominal pain, nausea, vomiting, diarrhea, dizziness, headache, hives, rash, itchy or swollen skin, cyanosis, light-headedness, confusion, weakness, drowsiness, palpitations, hyperpnea, seizures, hypotension, and trembling. Late symptoms include respiratory failure, paralysis, coma, and death (4,31757,65124,94064,94065). There are numerous documented reports of acute cyanide toxicity after ingestion of large quantities of apricot kernels and/or amygdalin (31757,31768,65124).
Long-term ingestion of apricot kernel can also cause chronic cyanide poisoning, with symptoms of goiter, thyroid cancer, optic nerve lesions, blindness, ataxia, hypertonia, and intellectual disability. Demyelinating lesions and neuromyopathies also occur secondary to chronic exposure. Lab values indicating chronic cyanide toxicity include increased blood thiocyanate, elevated liver enzymes, and low oxygen saturation (4,94064,97500). There are case reports of chronic cyanide toxicity after long-term consumption of apricot kernels and/or amygdalin (94064,97500).
General ...Topically, emu oil seems to be well tolerated.
General ...Side effects of jojoba are mainly limited to contact dermatitis and gastrointestinal concerns in animals fed large amounts of jojoba meal.
Dermatologic ...Contact dermatitis to jojoba oil has been described in case reports (57197,57186).
Endocrine ...Levels of plasma growth hormone and thyroxine increased and levels of plasma insulin-like growth factor-I and triiodothyronine decreased in animals fed diets of 4% jojoba meal (57195).
Gastrointestinal ...In animals fed jojoba oil for four weeks 2-9% of diet), necropsy and histopathological evaluation revealed an apparent distension of the small intestine and marked intestinal changes characterized by massive vacuolization and lipid deposition in the enterocytes, accompanied by distension of the villi and an increased cell turnover of small intestinal cells (57189).
Genitourinary ...In broiler breeding females fed jojoba meal, the size of the eggs laid were smaller and the overall production rate was lower than birds not fed jojoba (57164). Ovary and oviduct weights were also reduced. In female rats fed defatted jojoba meal or pure simmondsin, the number of corpora lutea on gestation day 16 as reduced, and this was thought to be due to decreased food intake in this group (57199). Fetal and placental weights were also reduced in these groups.
Hematologic ...In animals fed jojoba oil for four weeks 2-9% of diet), there was a dose related increase in white blood cell count (57189).
General
...Orally, topically, or intranasally, sesame seems to be well tolerated.
Most Common Adverse Effects:
All routes of administration: Allergic reactions.
Dermatologic ...In a small clinical study, one patient using a cream containing sesame oil as well as aqueous extracts of guggul and Allium ampeloprasum complained of rash at the application site (105751). It is unclear if this reaction was due to sesame, other ingredients, or other factors.
Gastrointestinal ...There was a single case of diarrhea associated with oral sesame in a clinical trial (108356).
Immunologic
...Multiple cases of allergic response to sesame seed occurring after occupational, topical, intramuscular, or oral exposure have been reported (28157,28158,28159,28160,28161,28162,28163,28166,28167,28183)(28184,28185,28186,28188,108348).
One study found that up to 0.5% of the United States population reports having a sesame allergy, and 0.23% of the population meets criteria for an IgE-mediated allergic reaction to sesame (100501). Allergic symptoms may be dermatologic, such as angioedema (28160,28167,108348), cheilitis (28207), dermatitis (28157,28166,28182,28185,28186), edema (28159), erythema (28167), pruritis (28167,108348), purpura (28188), flushing (108348), and urticaria (28159,28160,28162,108348); musculoskeletal (28188); respiratory, such as asthma (28159,28162), rhinitis (28162), wheezing (28167), and general breathing difficulties (108348); gastrointestinal, such as vomiting (28159,108348); and others such as conjunctivitis (28159), anaphylactic shock (28157,28159,28160,28167,28177,28178,28179,28180,28204,108348), and hemodynamic modifications (28169). In Canada, sesame accounted for 4% of pediatric food-induced anaphylaxis reactions presenting to emergency departments over a 10-year period. The majority of cases were mild to moderate in severity and occurred within 2 hours of exposure; however, about 3% occurred 2-8 hours after exposure. Epinephrine was the most common treatment, followed by antihistamines, inhaled beta-agonists, and corticosteroids (108348).
Approximately one-third of patients with IgE-mediated sesame allergy have reported previous use of epinephrine due to this allergy (100501). There is evidence that IgE-mediated sesame allergy is influenced by both genetic and environmental factors; there was a high correlation of the allergy between family members, especially siblings (28175).
Allergens believed to be responsible for sesame seed hypersensitivity include beta-globulin (28213); sesamol, sesamolin, and sesamin (28182,28207); storage proteins including ses i 1 and ses i 2 (2S albumins) (28132,28187,28211,28212,28216,28217), ses i 3 (a 7S vicilin-type globulin) (28187,28214), ses i 4 (28158), ses i 5 (28158), ses i 6 (an 11S globulin) (28132,28215), and ses i 7 (28215). Typically allergens in sesame seeds that cause reactions after oral intake have molecular weights ranging from 8-62 kDa (28208,28210).
Pulmonary/Respiratory ...In clinical trials involving a sesame oil nasal spray, minor adverse effects included adverse smell, oil dripping from the nose, and nasal blockage (27659).
General ...Orally, shark liver oil seems to be well tolerated.
Cardiovascular ...Orally, shark liver oil 15 grams daily for 4 weeks has been shown to increase levels of total cholesterol by about 41. 5 mg/dL to borderline high, and decrease levels of high-density lipoprotein (HDL) cholesterol, in healthy adults. These changes in lipid levels normalized after discontinuation of shark liver oil (94284). Lower doses of shark liver oil, 1.5 grams daily for 8 weeks, do not appear to significantly affect total cholesterol, low-density lipoprotein (LDL) cholesterol, HDL cholesterol or triglyceride levels in healthy patients (94286).
Gastrointestinal ...Orally, shark liver oil has been reported to cause gastrointestinal side effects in one clinical study when taken in doses of 1. 5 grams daily; however, these side effects did not occur more frequently than with placebo (94286).
Hepatic ...Orally, a case of severe acute hepatitis probably related to use of shark liver oil twice daily for 2 weeks has been reported. The patient presented with abdominal discomfort, jaundice, malaise, pruritus, and elevated levels of bilirubin and liver enzymes. Other potential causes were ruled out (94285).
Pulmonary/Respiratory ...Both shark liver oil and the constituent squalene have been associated with cases of aspiration and subsequent lipoid pneumonia (2546,2547,2548).
General
...Topically and intravenously, squalamine seems to be well tolerated; however, a thorough safety evaluation has not been conducted.
Most Common Adverse Effects:
Intravenously: Fatigue, loss of appetite, myalgia, nausea, transaminitis, vomiting.
Gastrointestinal ...Intravenously, squalamine has been associated with reports of mild to moderate nausea and vomiting, as well as mild loss of appetite, in clinical research (96040).
Hepatic ...Intravenously, squalamine at doses above 192 mg/m2 daily has been associated with reports of elevated hepatic transaminase levels. Levels of aspartate aminotransferase and alanine aminotransferase were about 5 to over 20 times above upper normal levels in some patients. The increased levels were noted 2-5 days after beginning squalamine. Both values returned to baseline within 6-23 days. These patients also had mildly elevated alkaline phosphatase and lactate dehydrogenase and one patient had a moderately elevated bilirubin level (96040).
Musculoskeletal ...Intravenously, squalamine has been associated with reports of mild to moderate myalgias and muscle cramps in clinical research (96040).
Neurologic/CNS ...Intravenously, squalamine has been associated with reports of mild to moderate fatigue in clinical research (96040).