Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal Candidiasis

Inclusion Criteria:

1. At least 19 years old at the time of consent.

2. Participants must be diagnosed with clinical candidiasis.

3. Have no acute illnesses or hospitalizations within 30 days prior to enrollment, noplanned procedures during the anticipated study participation, and no newlydiagnosed chronic illnesses that are not deemed stable by the participant's primarycare physician), in the opinion of the Investigator, based on medical history (i.e.,absence of any clinically relevant abnormality) during Screening.

4. Participants must not have been part of any clinical trial for the past 30 days andmay not be taking any other investigational therapy related to treatment ofcandidiasis.

5. If female, be surgically sterile or post-menopausal (no menses for at least 12months), or if of childbearing potential, must be using an acceptable method ofcontraception such as a combination estrogen/progestin hormonal contraceptive (oralor injected) for at least 1 month prior to Day -14, or such items as an intrauterinedevice (IUD), intrauterine system (IUS), transdermal hormonal implant, vaginalhormonal ring, or 2 forms of the following: diaphragm, cervical cap, patch, condom,spermicide, or sponge. Total abstinence is permitted. If local regulations deviatefrom the previously listed contraception methods to prevent pregnancy, localrequirements will apply. In addition, females of childbearing potential must agreeto continue to use their method of birth control for the duration of the study.

6. If male, be surgically sterile, or agree to use appropriate contraception (latexcondom with spermicide) when engaging in sexual activity and agree to not donatesperm for the duration of the study.

7. Be able to understand and provide written, informed consent.

8. Must be willing and able to manage a treatment regimen and attend assessment studyvisits.

Exclusion Criteria:

1. Participants with mucosal/oral ulceration

2. No prior antifungal therapies for a minimum 2-week prior to enrollment

3. Participants with other conditions considered by the investigator to be reasons fordisqualification that may jeopardize patient safety or interfere with the objectivesof the trial (e.g., acute illness or exacerbation of chronic illness, lack ofmotivation, history of poor compliance, neurologically or mentally disabled)

4. Females who are breastfeeding, pregnant, or attempting to become pregnant.

5. Participants with hypersensitivity to any of the product's ingredients.