. Author manuscript; available in PMC: 2021 Mar 1.

Published in final edited form as: Contemp Clin Trials. 2020 Jan 22;90:105938. doi: 10.1016/j.cct.2020.105938

Table 6.

Analysis Groups

Intention-to-Treat (ITT)

Includes all enrolled participants who receive a treatment assignment.

Microbiologically Eligible

Includes the subset of Intention-to-Treat participants who, in addition, have culture confirmation of drug-susceptible tuberculosis at study entry. Participants classified as ‘not assessable’ will be considered to have an unfavorable outcome.

Assessable

Includes the subset of Microbiologically Eligible participants who, in addition, are not classified as ‘not assessable’.

Adherent Per-Protocol

Includes the subset of Assessable participants who, in addition, complete assigned study treatment and follow-up.