Blinding: Procedure used to prevent one or more parties involved in the study from knowing about participation in the treatment. Single-blinding generally refers to when the participant(s) do(es) not know which type of intervention they were subjected to (control or intervention), whereas double-blinding occurs when the participant(s), investigator(s), monitor(s), and, in some cases, the data analyst, do not know which type of intervention the volunteer was subjected to.

Protocol Amendment: Written description of formal changes or clarifications to the protocol.

Clinical Trial: Investigation in human beings intended to discover or verify the clinical, pharmaceutical, and/or other pharmacodynamic effects of a product.

Prospectively registered study: According to the World Health Organization (WHO) and the International Committee of Medical Journal Editors (ICMJE), prospectively registered studies are those in which the registration approval date precedes the recruitment date of the first volunteer. This means that study-related information is registered before it begins in practice.

Retrospectively registered study: According to the World Health Organization (WHO) and the International Committee of Medical Journal Editors (ICMJE), retrospectively registered studies are those in which the recruitment date of the first volunteer precedes the study registration approval date.

Adverse Event: Any untoward medical occurrence in a patient or clinical research subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Consequently, an adverse event (AE) can be any unfavorable and unintended sign, symptom, or disease (including an abnormal laboratory finding) associated with the use of a medicinal product under investigation, whether related to it or not.

Investigator: Person responsible for conducting a clinical study at the site where it takes place. If a study is conducted by a team of individuals, the investigator is the leader of the group, designated as the principal investigator.

Comprehensive Opinion (Parecer Consubstanciado): Formal opinion issued in response to a consultation. Regarding the opinion issued by the CEP/CONEP system, it can be status-designated as: approved, not approved, pending, or withdrawn. Plataforma Brasil is the body responsible for issuing the Comprehensive Opinion (Parecer Consubstanciado).

Sponsor: Individual, company, institution, or organization responsible for the implementation, management, and/or financing of a clinical study.

Randomization: Process of randomly assigning study subjects to treatment or control groups to reduce bias (systematic error).

Pending Status (ReBEC): Indicates that your registration is currently in the review phase and no action is required from the registrant.

Informed Consent Form (ICF / TCLE): Document that guarantees the research participant respect for their rights.