Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Security is measured through the following variables: - Adverse events (event number, type, frequency: Yes, No, Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related to adverse events, Duration: hours, days, months, ratio causality: remote, possible, likely, very likely; Result: Fully resolved Resolved with sequelae, in improving conditions, conditions still present and unchanged, worsening, Death, Treatment indicated: type and dosage of medication, treatment time). - Hematological and biochemical determinations (values ??of hematocrit, platelet count, transaminases, bilirubin, urea, creatinine, glomerular filtration rate). Response time (of the above variables): 24 hours, 15 days and at months 3, 6, 9 and 12 post-treatment.
Key secondary outcomes:
- Histological Evaluation (Stage of injury). - colposcopic evaluation (number, size and scale of colposcopic lesions measurable). - Presence of HPV in biopsies (Yes, No). - surrogate markers of response (molecular parameters such as Angiogenesis and Induction of Apoptosis). Response time (of the above variables): at 15 days of completion of treatment.