Please select the eligibility criteria that correspond to the clinical trial below.
Title: Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis.
Brief Summary: This study evaluates the effect of the medical device "Excilor® Forte" in the treatment of toenail onychomycosis. Half of the participants will receive the tested product and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during 6 months.


Options:
A: Inclusion Criteria:

* Presence of onychomycosis of the target toenail
* A positive fungal culture from the target toenail

Exclusion Criteria:

* Any disease or condition that might cause nail abnormalities or may interfere with clinical evaluations
* Presence of tinea pedis (athletes foot)
* Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
B: Inclusion Criteria:

* Subject having given her/his informed, written consent.

  * Subject cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
  * Subject being psychologically able to understand information and to give their/his/her consent.
  * Age: more than 18 years.
  * Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablet).
  * Subject with positive KOH staining.
  * Subject having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion.
  * Female subjects of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after study end.

Exclusion Criteria:

* Subject considered by the Investigator likely to be non-compliant with the protocol.
* Patient enrolled in another clinical trial during the test period.

  · Woman being pregnant, nursing or planning a pregnancy during the course of this study.
* Subject having a known allergy to one of the constituents of the tested products.
* Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology...
* Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).
C: Inclusion Criteria:

* Subjects with a mild to moderate Distal Subungual Onychomycosis (DSO) on at least 1 great toenail chosen as a Target nail
* Subjects must have maximum of 50% of nail distal edge involved
* Subjects with positive mycological results (direct microscopy and culture) of the Target nail for dermatophytes or Yeast (including Candida) at Screening

Exclusion Criteria:

* Subjects with clinically important abnormal physical findings at the Screening/Baseline visit
* Subjects with Lichen planus, eczema, psoriasis, or other abnormalities of the nail unit
* Subjects with known immunodeficiencies, radiation therapy, immune suppressive drugs
D: Inclusion Criteria:

* Clinically diagnosed onychomycosis of the target nail
* Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected
* Has a positive KOH examination from the target nail
* Has a positive dermatophyte culture from the target nail

Exclusion Criteria:

* Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug
* Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis
* Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit
* Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period

Answer: B