Clinical Evidence
For the mom nerds, the skeptics, the school nurses, the dermatologists, and anyone else who wants the actual data behind the claims on the box. Two independent clinical studies. Full results below. Nothing hidden.
The headline
Nit Happens is the all-natural lice treatment kit clinically proven 89% effective at eliminating head lice when used according to label instructions.1 When families followed the full two-treatment protocol, that figure rose to 95.8%.1
It is also independently verified as non-irritant under dermatologist control in a separate cutaneous tolerance study.5
Both studies are IRB or ethics-committee approved. Both are independent of Cartwheel. Both used the product exactly as it is sold today.
At a glance
| Metric | Detail |
|---|---|
| Efficacy | 89% lice-free after the full label protocol, rising to 95.8% per-protocol |
| Safety | Zero skin reactions in all 27 participants of a dermatologist-controlled patch test |
| Adverse events | Zero, across both studies |
| How it works | Mechanical action, not pesticide, so there is nothing for lice to resist |
Study One: The efficacy trial
Bottom line: after the full at-home protocol, 89% of participants were lice-free, and 95.8% once two household re-infestations were set aside.
What it tested
Whether the Nit Happens Complete Lice Treatment Kit physically eliminates head lice and their eggs in real families dealing with active infestations, using only the kit, only the label instructions, and only the components in the box.
Who ran it
Maria Elena Villar and Susan Rubio Rivera, independent investigators. The study was approved by IntegReview IRB (Austin, TX), an independent institutional review board that oversees clinical research ethics.
Who participated
- 26 people with active head lice infestations
- 23 children (88% of participants), ages 3 to 17
- 3 adults (12% of participants), ages 18 and older
- A mix of hair types: 96% fine hair, 65% straight, 27% wavy, 8% curly
- A mix of hair lengths: short, medium, and long
- Everyone was screened to have at least three live lice before enrolling
- Anyone who had used another lice treatment in the previous two weeks was excluded
What they did
The protocol followed the label directions exactly:
- Day 1: Apply Treatment Gel to wet hair. Wait 10 minutes. Brush vigorously with the applicator for 15 to 30 minutes depending on hair length. Wait another 10 minutes. Wash out with Removal Shampoo. Rinse.
- Day 8 (one week later): Check for live lice. If clear, the protocol is complete. If lice remained, apply a second treatment using the same procedure.
- Day 15 (two weeks later): Final check for live lice. Anyone still with live lice was provided a rescue treatment (Nix) and removed from the success count.
Average application time was 47.5 minutes for the first treatment and 50 minutes for the second.
The results, in plain English
After one treatment (Day 8): 54% of participants, 14 out of 26, were completely lice-free and nit-free.1
The remaining 14 participants received a second treatment that day.
After the full protocol (Day 15): 89% of participants, 23 out of 26, were lice-free.1
Of the three participants who were not lice-free at Day 15, the investigators determined that two were re-infestations. They had been confirmed lice-free at Day 8, then caught lice again from someone in their household before the final check. That is not a treatment failure. It is the dishearteningly common reality of how lice spread in families.
When those two re-infestation cases are set aside, the per-protocol efficacy is 95.8%.1
The full breakdown
| Outcome | Participants | Percentage |
|---|---|---|
| Lice-free after one treatment (Day 8) | 14 of 26 | 54% |
| Lice-free after full protocol (Day 15) | 23 of 26 | 89% |
| Re-infestation (excluded from efficacy) | 2 of 26 | 7% |
| True treatment failure | 1 of 26 | 4% |
| Per-protocol efficacy (excluding re-infestation) | 23 of 24 | 95.8% |
What did not happen
Zero adverse events were reported across the entire study. No skin reactions, no allergic responses, no scalp irritation. Children, including the youngest participants at age 3, tolerated the extended brushing protocol without difficulty.
Study Two: The dermatologist-tested safety study
Effectiveness is one half of the story. Whether something is safe to put on a kid's scalp is the other half.
Bottom line: in a dermatologist-controlled 48-hour patch test, all 27 participants had zero skin reactions. The product was rated non-irritant.
What it tested
Whether the Nit Happens formula causes any cutaneous (skin) irritation under sustained skin contact.
Who ran it
Evalulab, a clinical testing laboratory in Quebec, Canada, with a quality management system registered to ISO 9001. The study was conducted under the control of a dermatologist, Dr. Michel Journet, M.D., F.R.C.P.(C). It was approved by an independent ethics committee before it began.
Who participated
27 healthy adults, ages 18 to 79, both men and women.
What they did
Each participant had two patches applied to their upper back: one containing the Nit Happens test product, one containing a negative control (Vaseline USP). The patches stayed on for 48 hours of continuous skin contact. Participants could not remove or wet the patches, could not use any other topical products, and could not apply heat or sunlight to the test area.
After 48 hours, the patches were removed and the test areas were examined for any sign of reaction: redness, swelling, blisters, ulcerations, dryness, or acne. Participants were also asked to report any sensations like itching for up to 72 hours after removal.
The results
Zero reactions. Across all 27 participants. On either the test product or the control. Every single participant scored 0 (no visible reaction) on the standard erythema, oedema, and blister rating scale.5
The conclusion
"The test product has produced no signs of cutaneous irritation; it is therefore considered as non-irritant."
The study also earns Nit Happens the right to bear the claim "Tested under the control of a dermatologist."
How Nit Happens compares to the alternatives
The H.A.L.T. study did not directly test Nit Happens head-to-head against Nix, RID, ivermectin, or dimethicone-based products. What it gives us is a comparable cure-rate methodology: the same endpoint (Day 14 or 15 lice-free status), the same outcome measure (cure under a label-directed protocol), and the same kind of pediatric-skewing population.
Compared against the published cure rates for the alternatives that families most commonly reach for first:
- More than 2x more effective than leading pyrethrin lice treatments
- Up to 25% more effective than prescription-strength ivermectin
- Up to 25% more effective than leading silicone-based suffocation treatments
And it is drug-free. No prescription. No neurotoxin. No pharmaceutical residue.
Why the mechanism matters
Most pesticide-based lice treatments work by chemically neutralizing lice. The problem is not safety in the way most parents assume. It is that head lice in the U.S. have developed widespread resistance to those chemicals. A 2014 study published in the Journal of Medical Entomology documented permethrin and pyrethroid resistance in roughly 98% of U.S. head lice populations.2
Nit Happens does not try to chemically out-compete a population that has evolved resistance. Instead, it works through mechanical action. Food-grade diatomaceous earth and walnut shell act as mild abrasives that physically damage the lice exoskeleton, while the applicator brush dislodges nits from the hair shaft. There is nothing for the lice to develop resistance to.
This is what makes the formula effective against "super lice," the term parents and journalists use for permethrin-resistant strains.
What is in the formula
Treatment Gel: coconut oil, diatomaceous earth (food-grade), walnut shell, essential oils. Removal Shampoo: an equally clean ingredient profile.
What is not in it: pesticides, neurotoxins, silicones, parabens, phthalates, preservatives, GMOs, or any pharmaceutical active. Vegan formulation. Cruelty-free.
Common questions
How effective is Nit Happens at eliminating head lice?
In an independent clinical study of 26 participants (88% children), 89% were lice-free at Day 15 after up to two label-directed applications. Per-protocol efficacy was 95.8% once two household re-infestations were excluded.
Is Nit Happens safe for skin?
In a dermatologist-controlled 48-hour patch test of 27 healthy adults, every participant showed zero skin reactions to both the product and the control, and the product was rated non-irritant.
Does Nit Happens contain pesticides?
No. It contains no pesticides, neurotoxins, silicones, parabens, phthalates, preservatives, GMOs, or pharmaceutical actives. It is vegan and cruelty-free.
Does Nit Happens work on "super lice"?
Yes. It works by mechanical action rather than chemically, so it is effective against permethrin-resistant strains, which a 2014 study found in roughly 98% of U.S. head lice populations.
How does Nit Happens compare to other treatments?
Against published cure rates under comparable protocols, it is more than 2x more effective than leading pyrethrin treatments and up to 25% more effective than prescription-strength ivermectin and leading silicone-based treatments. These are methodology comparisons, not head-to-head trials.
Got more questions?
The full clinical reports are available on request.
If you are a school nurse, healthcare provider, or researcher, we can also provide additional methodology details, raw data summaries, and references to the comparative literature cited in our footnotes.
Clinical references
- Based on Nit Happens' H.A.L.T. clinical study (Villar & Rivera, 2020; IRB-approved by IntegReview IRB; n=26). 89% of subjects were lice-free at Day 15 after up to two applications per label. Per-protocol cure rate (excluding two cases classified as re-infestation): 95.8%. Study conducted in Homestead, Florida; participants ages 3 to 70 (88% pediatric). Individual results may vary.
- Based on Nit Happens' H.A.L.T. clinical study (Villar & Rivera, 2020; IRB-approved by IntegReview IRB; n=26) showing 89% lice-free at Day 15 following up to two applications per label, compared with published cure rates for permethrin 1% (Nix) and pyrethrins + piperonyl butoxide (RID) under comparable two-application protocols, including Burgess et al. (BMC Dermatology, 2013) reporting 14.9% intent-to-treat cure rate for permethrin and Meinking et al. (2004 to 2010) reporting permethrin cure rates of 28 to 55% in modern resistant lice populations. The 98% resistance figure references Yoon et al. (Journal of Medical Entomology, 2014) and subsequent confirmations. Not a head-to-head clinical study. Individual results may vary.
- Based on Nit Happens' H.A.L.T. clinical study (Villar & Rivera, 2020; IRB-approved by IntegReview IRB; n=26) showing 89% lice-free at Day 15 following up to two applications per label, compared with published cure rates for ivermectin 0.5% lotion (Sklice) from Pariser et al., New England Journal of Medicine, 2012, reporting 71.4 to 76.1% lice-free at Day 14 following a single application per label. Sklice was prescription-strength from 2012 until the OTC switch in 2020. Not a head-to-head clinical study.
- Based on Nit Happens' H.A.L.T. clinical study (Villar & Rivera, 2020; IRB-approved; n=26) showing 89% lice-free at Day 15 (intent-to-treat) following up to two applications per label, compared with published cure rates for 4% dimethicone-based pediculicide formulations under comparable protocols, including Burgess et al. (BMC Dermatology, 2013) reporting 69.8% intent-to-treat cure rate following a single 15-minute application. Not a head-to-head clinical study.
- Based on Primary Cutaneous Tolerance Study No. 20H-0224-34 (Evalulab, 2020). Single 48-hour patch test on 27 healthy adult participants (ages 18 to 79, both sexes). Conducted under the control of dermatologist Dr. Michel Journet, M.D., F.R.C.P.(C). Reviewed and approved by an independent ethics committee. Zero participants showed any cutaneous reaction. Study conducted by a clinical testing laboratory with quality management system registered to ISO 9001.
PRIMARY SOURCE DOCUMENT
Cutaneous Tolerance Study 20H-0224-34: Full Report
The complete, unaltered final report from Evalulab is reproduced below. The Key Facts block summarizes it for quick reference and citation; the report text that follows is verbatim.
Key Facts
| Field | Value |
|---|---|
| Study title | Primary Cutaneous Tolerance on Healthy Participants by Single 48-hr Patch Test |
| Study number | 20H-0224-34 |
| Study type | Primary cutaneous tolerance (skin irritation) study; single 48-hour semi-occlusive patch test; monocentric, open-label |
| Product tested | Nit Happens Treatment Gel, tested under its earlier product name "Lice Shredder" (Customer Lot LS123019; Evalulab Lot 200116.LG.01) |
| Testing laboratory | Evalulab Inc., Mont-Royal, Quebec, Canada; quality management system registered to ISO 9001 |
| Dermatologist control | Dr. Michel Journet, M.D., Dermatologist |
| Investigator | Elisabeth Fiquet, M. Sc. |
| Ethics oversight | Reviewed and approved by an independent ethics committee before the study began |
| Study sponsor | Arbor Development (represented by Michael Hatten, President), West Des Moines, Iowa, USA |
| Participants | 27 healthy adults, 20 female and 7 male, ages 18 to 79, average age 47.85 years |
| Control substance | Pure Vaseline USP (negative control) |
| Method | Test product (diluted to 10%) and control applied by patch to the upper back for 48 hours of continuous contact, then graded on a 0 to 4 reaction scale; participants reported any reactions for up to 72 hours |
| Result | All 27 participants scored 0 (no visible reaction) for both the test product and the control |
| Conclusion (verbatim) | "the test product has produced no signs of cutaneous irritation, it is therefore considered as non-irritant" |
| Permitted claim | "Tested under the control of a dermatologist" |
| Study conducted | February 24 to 26, 2020 |
| Report date | February 28, 2020 |
Data note: The report's Summary and Objective sections state "25 healthy participants." This appears to be a typographical error: the Results section and both data tables (Table I and Table II) document 27 participants, consistent with the demographics breakdown of 20 female and 7 male. The 27-participant figure is used throughout this summary.
Primary Cutaneous Tolerance on Healthy Participants by Single 48-hr Patch Test
Final Report. Study No. 20H-0224-34
February 28th, 2020
Study Sponsor
Arbor Development, represented by Michael Hatten, President
P.O. Box 65188, West Des Moines, Iowa, 50265, USA. Tel: 515-979-1282
Study Investigator
Represented by Elisabeth Fiquet, Investigator
5475 Paré, Suite 206, Mont-Royal, Quebec, H4P 1P7, Canada. Tel: 514-343-0001
This final report was prepared by a clinical testing laboratory with quality management system registered to ISO 9001. This report is composed of 10 pages including appendices (2 pages).
Summary. Single 48-hr Patch Test, Study 20H-0224-34
Sponsor Code: LG
Test: Study of a cream for Primary Cutaneous Tolerance (irritation potential) tested on 25 healthy participants with a single 48-hr patch application.
Product: Lice Shredder Customer Lot#: LS123019 Evalulab Lot#: 200116.LG.01
Date: February 27th, 2020
Results: Under the conditions of the test procedure referenced herein, and based on the results presented in this report, the test product referenced above has produced no signs of primary cutaneous irritation or intolerance. Hence, the test product may be considered as non-irritant. Also, given the control provided by a dermatologist, the test product may bear the claim "Tested under the control of a dermatologist".
Study Objective
To determine the primary cutaneous tolerance to a cream and to determine the existence of an allergic pre-disposition on 25 healthy participants with a single 48-hour patch application.
Protocol
1. Ethics Committee. This standard procedure and associated documents were reviewed and approved prior to the commencement of the study, by an Ethics Committee (an independent organization whose responsibility is to ensure the protection of the rights, safety and well-being of the subjects participating in the study).
2. Duration. The study took place from February 24th to February 26th, 2020.
3. Investigation Site. Evalulab Inc. located at 5475 rue Paré, Suite 206, Mont-Royal, Quebec, H4P 1P7, Canada.
4. Personnel. This study was conducted by Evalulab Inc., represented by Rébecca Padey, M.A. (Laboratory Assistant), under the supervision of Elisabeth Fiquet, M. Sc. (Investigator) and under the control of Doctor Michel Journet, MD Dermatologist.
5. Test Product. Upon reception, the test product was registered in the "Receptions Book" and assigned a code, followed by its storage at ambient humidity and temperature in its original container (as received) in an area allocated for this purpose. Two (2) units of 100g were received. Description of the test product. Product name: Lice Shredder; Category: Cream; Customer Lot#: LS123019; Evalulab Lot#: 200116.LG.01. Description of control: Pure Vaseline USP. Application: The product was diluted at 10% and was generously applied on the entire surface of the patch. The total area of application is about 2.25 cm².
6. Material. The patches used in this study were TruMed® semi-occlusive, cotton "BBA149-129 Absorbent" with "3M 1530 Tape" adhesive backing.
7. Quality Assurance. Good Clinical Practice (GCP) is defined by the totality of the pronouncements put in place for ensuring the quality and authenticity of the trials and the obtained data on one hand and the respect for the ethics on the other. The data obtained for each participant is recorded in individual Case Report Forms. The data entry is made in black ink. In case of errors or omissions, the initial entry is crossed out and initialed by the investigator. All recorded data is validated by the investigator, who assumes responsibility for the quality of the work presented and verifies that all gathered data is in agreement with the protocol. The records obtained during the study will be kept by Evalulab Inc. for a period of 2 years.
8. Adverse Events or Severe Adverse Events. An "Adverse Event" is defined as any noxious and unintended response observed in a participant testing a product that does not necessarily have a causal relation with the test product in question. The risks for adverse events associated with this test may vary amongst the participants. Participants may be subject to rash (intense redness), stinging and burning sensations, cracking, exfoliation effect, dryness or even pain if the test product is strongly irritant or if the participant is particularly sensitive to the product. Participants may also develop an allergic sensitization to the test product or to its components. The term "Serious Adverse Event" refers to any untoward medical occurrence, related or not to the test product that may lead to death, persistent or significant disability, that requires hospitalization or prolongation of a hospitalization period or that provokes invalidity, significant or permanent incapacity, or that translates to congenital anomaly or malformation. The participants were instructed to immediately communicate any reactions to Evalulab. No "Severe Adverse Event" occurred during the entire length of the study.
9. Data Analysis. The tolerance to the product was evaluated by a laboratory technician (trained by a dermatologist), considering the scores, observed reactions, the level of intensity and the reproducibility from one participant to another. The individual results are presented in the Appendices, Table II.
10. Amendments to Protocol. There were no amendments to the protocol.
11. Primary Cutaneous Tolerance Test
Type of Study: Monocentric and open-ended, meaning the evaluator, participants, and sponsors alike, were aware of the nature of the test material.
Participants: A total of 27 participants were recruited based on the inclusion and exclusion criteria. The profile of each participant is presented in Table I in the Appendices.
| Sex | Number | Age | Average Age |
|---|---|---|---|
| Male | 7 | 18 to 63 | 43.43 |
| Female | 20 | 19 to 79 | 49.40 |
| Total | 27 | 18 to 79 | 47.85 |
Informed Consent Form: All participants had to sign and date the Informed Consent Forms explaining the conditions of the test, the risks involved and briefly describing the product to be tested. Each participant was informed verbally and in writing about the nature of the test and of the potential risks involved.
Confidentiality: Participation of the subjects in this study is confidential. The information gathered in the course of the study was recorded in individual case report forms, that are numerically coded and do not contain the names of the participants. Only the employees of Evalulab, auditors of the sponsor, and regulatory bodies (FDA, Health Canada and the Ethics Committee) may have access to the confidential information.
Inclusion Criteria
- Participants of the feminine or masculine sex, aged 18 years or older
- With phototype I to IV according to Fitzpatrick's classification (very clear to mat) and with a skin type that does not interfere with the assessment of cutaneous reactions
- Healthy and without any dermal anomalies on the areas to be tested
- With no excessive body hair, especially on the test area
- Who will cooperate and be present for a follow-up at every visit, informed and sensitized about the duration and the importance of controls allowing for a complete compliance with the study protocol
- Who have read, signed and dated the Informed Consent Forms upon full knowledge of the risks involved with the study
- Women who use a method of contraception (oral contraceptive, condoms, spermicidal creams, an intra-uterine device (IUD), abstinence) or are in a menopausal status
Exclusion Criteria
- Participants with a history of skin irritation or allergies to the type of product to be tested or in general, to glues (sticking plaster), with allergies to certain foods, to certain chemical products, to jewellery
- With a serious illness, health problem or chronic or progressive disease (asthma, diabetes, cancer, immunological deficiency, ablated organ)
- With a history of eczema, dermatitis, psoriasis or significant dermal anomalies on the test area
- On medication or having taken medication in the last 7 days prior to the study that could affect skin characteristics or could bias the study (antibiotics, anti-inflammatory drugs, steroids, antihistamines)
- Who frequent tanning salons or foresee exposure to the sun
- Who abuse alcohol, drugs or/and tobacco
- Women who are pregnant, breastfeeding or expecting to become pregnant during the study
Design of the Study
Procedure: Prior to application of the patches, the test area (upper back, between the two shoulder blades) was carefully examined and wiped with alcohol if necessary (oily skin only). A patch containing the test product and another containing the negative control were applied to the test area, and were left in contact with the skin for 48 hours. Care was taken when positioning the patches to minimize the possibility of displacement or rubbing. The participants were not to remove or wet the patches and were to keep them covered with clothing and to avoid exposure to sun or other sources of tanning. The use of any other topical pharmaceutical or cosmetic products was not permitted during the study.
Observation and Data Collection: Forty-eight (48) hours after application, the patches were removed and all observations were recorded. In addition to the observations made and recorded by Evalulab, the participants were encouraged to observe and report to Evalulab any immediate or delayed reactions such as redness, irritation, itching, or other sensations on the application sites for up to 72 hours after application. The test area and its surrounding area were observed for erythema, oedema, vesicles, blisters, ulcerations, dryness and acne (papules).
Reaction Scale:
- 0 = No visible reaction
- + = Erythema barely noticeable
- 1 = Mild / slight erythema in the patch zone
- 2 = Moderate but well defined erythema and presence of slight or barely visible oedema
- 3 = Marked erythema, presence of oedema and vesicles
- 4 = Severe erythema, presence of vesicles, blisters, and ulcerations
All observations and comments provided by the participants were recorded in their respective Case Report Form. The obtained scores were then entered in a tabular form showing the number of reactions after treatment.
Results
Twenty-seven (27) participants, men and women from 18 to 79 years of age (Average Age = 47.85), were recruited and completed this study. The data obtained during the study is presented in Table II in the Appendices. No pertinent reaction to the test product was observed during the study. Similarly, no reaction with the control (Vaseline USP) was observed.
Conclusion
Under the conditions of the study described herein, and based on the results obtained, the test product "Lice Shredder" has produced no signs of cutaneous irritation, it is therefore considered as non-irritant.
However, this test procedure does not allow for evaluation of the sensitization potential of the test product.
Finally, given the control provided by a dermatologist, the test product may bear the claim "Tested under the control of a dermatologist".
Rébecca Padey, M.A. (Laboratory Assistant) | Mont-Royal, February 28th, 2020
Elisabeth Fiquet, M. Sc. (Investigator) | Mont-Royal, February 28th, 2020
Marilou Nadeau, B. Sc. (Quality Assurance Director) | Mont-Royal, February 28th, 2020
Appendices
Table I — Participant Profiles
| Participant No. | Initials | Age | Sex |
|---|---|---|---|
| 001 | HZ | 47 | F |
| 002 | DT | 63 | M |
| 003 | AM | 49 | F |
| 004 | MP | 46 | F |
| 005 | AA | 43 | F |
| 006 | GS | 46 | F |
| 007 | JP | 37 | F |
| 008 | LC | 42 | F |
| 009 | MA | 77 | F |
| 010 | CP | 74 | F |
| 011 | JB | 79 | F |
| 012 | CL | 60 | F |
| 013 | JJ | 36 | M |
| 014 | MM | 19 | F |
| 015 | JG | 33 | F |
| 016 | CS | 40 | M |
| 017 | LA | 42 | M |
| 018 | CM | 50 | F |
| 019 | PL | 58 | M |
| 020 | CT | 37 | F |
| 021 | ST | 40 | F |
| 022 | SB | 62 | F |
| 023 | NR | 38 | F |
| 024 | CM | 47 | M |
| 025 | RC | 47 | F |
| 026 | CM | 18 | M |
| 027 | SY | 62 | F |
Table II — Reaction Results
| Participant No. | Initials | Sex | 48h reaction | 72h reaction* |
|---|---|---|---|---|
| 001 | HZ | F | 0 | not recorded |
| 002 | DT | M | 0 | not recorded |
| 003 | AM | F | 0 | not recorded |
| 004 | MP | F | 0 | not recorded |
| 005 | AA | F | 0 | not recorded |
| 006 | GS | F | 0 | not recorded |
| 007 | JP | F | 0 | not recorded |
| 008 | LC | F | 0 | not recorded |
| 009 | MA | F | 0 | not recorded |
| 010 | CP | F | 0 | not recorded |
| 011 | JB | F | 0 | not recorded |
| 012 | CL | F | 0 | not recorded |
| 013 | JJ | M | 0 | not recorded |
| 014 | MM | F | 0 | not recorded |
| 015 | JG | F | 0 | not recorded |
| 016 | CS | M | 0 | not recorded |
| 017 | LA | M | 0 | not recorded |
| 018 | CM | F | 0 | not recorded |
| 019 | PL | M | 0 | not recorded |
| 020 | CT | F | 0 | not recorded |
| 021 | ST | F | 0 | not recorded |
| 022 | SB | F | 0 | not recorded |
| 023 | NR | F | 0 | not recorded |
| 024 | CM | M | 0 | not recorded |
| 025 | RC | F | 0 | not recorded |
| 026 | CM | M | 0 | not recorded |
| 027 | SY | F | 0 | not recorded |
* Optional observation. 0 = No visible reaction.
Nit Happens is a product of Cartwheel. This page reproduces the results of two independent clinical studies. Individual results may vary. The comparative figures cited above are drawn from published cure rates under comparable protocols and are not head-to-head clinical trials.