Table 2 Schedule of visits and assessments at different points of the study protocol

Informed consent form

X

Inclusion/exclusion criteria

X

Randomization

X

Demographic data

X

Medical history

X

Size

X

Weight

X

X

X

X

X

X

X

Physical examination: vital signs

X

X

X

X

X

X

X

ECOG

X

X

Electrocardiogram

X

X

X

X

X

X

X

Study treatment

x

x

x

x

x

Hemogram

X

X

X

X

X

X

X

Biochemistry

X

X

X

X

X

X

X

Coagulation

X

X

X

X

X

X

X

Pregnancy test

X

Concomitant medication/antimicrobials

X

X

X

X

X

X

X

Adverse effects

X

X

X

X

X

X

Microbiological culture

X

X

X

X

X

X

X

Stool sample for microbiome analysis

X

X^b