Principles and Practice of Pharmaceutical Medicine

Did not take prohibited drug(s) between visit 1 and visit 3?

Had no Group A streptococci, mycobacteria observed post-therapy?

Was diary available?

Patient did not take more than 12 days of study drug (24 doses)?

Was not a clinical failure at Visit 3?

Was patient within visit 4 window (17–24 days) and clinically assessed at visit 4?

Did not take prohibited drug(s) between visit 3 and visit 4; and protocol compliant for entire study?

Step 15

Step 17

Step 16

Step 14

Step 13

Step 12

Step 11

Step 10

Step 9

Population assignment <Clinically evaluable>

Was the patient microbiologically evaluable?

Population assignment

Population assignment <Intent-to-treat> <Safety>

<Intent-to-treat> <Safety> <Clinically Evaluable>

No

No

No

Ye s

<Intent-to-treat> <Safety> <Clinically Evaluable> <Microbiologically Evaluable>

Figure 26.2 (Continued)

26.4 DATA PROCESSING 353