Table 5.

Different types of databases that will be used in the study

Types of database	Characteristics
Clinical trial database	will be programmed, tested and validated prior to study start and for every modification during the study if applicable
Quantitative behavioural/adherence/acceptability database	will be tested prior to use but will not be fully validated according to a clinical trial validation protocol. Revisions to this database after study start could be necessary when the initial qualitative research show that our questionnaires are not optimal.
Laboratory databases	will be developed for the laboratory tests done in batches. Data in these databases will be entered and double-checked manually by qualified laboratory professionals according to the study SOP. The data may be combined with variables from the above two databases for analysis.
Qualitative behavioural/adherence/acceptability data	IDI/FGD transcripts and coding