Study xxxx
Patient validity decision treeDid the patient receive
at least one dose of
study drug?Did the patient meet all
inclusion criteria?Had no
exclusion criteria?
or
pre-existing violation?Had no
Group A streptococci,
mycobacteria or
significant growth of
pure fungi observed
at visit 1?Had no contra-ear
infection developed
after baseline?Did the patient
have post baseline
response?Was the patient
a clinical failure?Population assignment
<Intent-to-treat>
<Safety>Did the patient receive
at least 3 days
(minimum of 5 doses)
of the treatment and
or 75% compliance
of prescribed dose?Did the patient take 10
days of treatment
with a minimum of
75% compliance?Go to Step 9Population assignment
<None>Step 1Step 2Step 3Step 4Step 5Step 6Step 6BStep 7Step 8NoYe sYe sYe sYe sYe sYe sYe sYe sYe sNoNoNoNoNoNoNoNoFigure 26.2 Derivation of study population352 CH26 DATA MANAGEMENT