Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phae 2 Efficacy Trial of AV Lotion for the Prevention of Cold Illness in Human Subjects
Brief Summary: The purpose of this of this study is to determine if 3804-250A can prevent the common cold caused by the rhinovirus when applied to the hands. The study will also evaluate whether 3804-250A can prevent rhinovirus infection or common cold illnesses.

The study will also evaluate the safety of 3804-250A.


Options:
A: Inclusion Criteria:

* Member of a designated elementary school classroom in the Avon school system
B: Inclusion Criteria:

(1) Infants (target child) will be eligible to participate in the study if they are:

1. They are in utero at the baseline survey
2. Their parents/guardians are planning to stay in the study village for the next 12 months (if a mother is planning to give birth at her natal home and then return, she will still be a candidate for enrollment)

(2) Children \< 36 months old at baseline that are living in the compound of a target child will be eligible to participate in diarrhea measurement if:

1. They are \< 36 months old at the baseline survey
2. Their parents/guardians are planning to stay in the study village for the next 12 months

(3) Children 18 - 27 months old at baseline that are living in the compound of a target child will be eligible to participate in intestinal parasite specimen collection if:

1. They are 18 - 27 months old at the baseline survey
2. Their parents/guardians are planning to stay in the study village for the next 12 months
C: Inclusion Criteria:

* Read and sign a copy of the approved Consent Form;
* 18-40 years of age;
* If a woman of child bearing potential (WOCBP) must have a negative urine pregnancy test and be using an effective method of birth control such as, but not limited to, birth control pills, contraceptive foam, diaphragm, IUD, vasectomized partner, abstinence, or condoms;
* Capable of compliance with the required study and sick visits (i.e., no planned travel commitments);
* Willing to follow study restrictions;
* Generally in good health based on medical history interview.

Exclusion Criteria:

* Current participation on any study;
* Participation in an investigational drug study within 30 days of enrollment;
* Participation within 30 days of enrollment on any study where the hands were the test site;
* Pregnancy (as determined by an urine pregnancy test), lactation or planning a pregnancy during the course of the study;
* Daily smoker;
* Current or significant history of sinusitis;
* Skin conditions on the hands or wrists that would interfere with the evaluations, such as scars, tattoos, uneven skin tones, or other conditions;
* Allergy to soaps, detergents, preservatives, citric acid, malic acid or ethanol;
* Immunological disorders (i.e., AIDS, HIV, systemic lupus erythematosis, rheumatoid arthritis);
* Current use or use within 7 days prior to randomization of any antibacterial medications for treatment of respiratory infections;
* Current use or use within 7 days enrollment of topical drugs (e.g. hydrocortisone or other corticosteroids) to treat skin conditions on the hands or wrists, except for localized treatment of minor cuts or scrapes;
* Occupational or other requirement for unusually frequent hand washing (i.e. health care worker, food service worker);
* Currently suffering from respiratory allergies or a history of seasonal respiratory allergies that are normally active during the study period;
* History of dermatologic disease on the hands, wrists or arms;
* History of 3rd degree burns and/or skin grafts on the hands or wrists;
* History of significant or frequent skin and soft tissue infections;
* Use of androgens, immunomodulators (such as growth factors, systemic corticosteroids, immune globulin, interleukins, interferons) or immunosuppressive medications within 30 days prior to study entry.
* Erythema score of 1.0 and/or dryness scores on the hands at enrollment of greater than Grade 0;
* Subject does not experience colds;
* The subjects from TM\&R-0062-08-TXC who were discontinued for irritation, experienced test product related skin reactions or were withdrawn from the study or excluded from the per-protocol analysis for non-compliance.
D: Inclusion Criteria: Children between 0 and 3 years old enrolled in the aforementioned DCCs, attended the DCCs for at least 15 hours per week and whose parents/guardians had signed an informed consent document were included.

Exclusion Criteria: Children whit chronic illnesses or medication that could affect their likelihood of contracting an infection. Families who used hydroalcoholic gel prior to the start of the study and/or antiseptic soaps in the control group.

Answer: C