Table 2.

Schematic schedule of the clinical trial to evaluate the safety and efficacy of Alkalihalobacillus clausii 088AE on antibiotic-associated diarrhea (AAD) patients.

Visits	Visit 01 (Day 1)a	Visit 02 (Day 2)b	Visit 03 (Day 3)c	Visit 04 (Day 5)d	Visit 05 (Day 8)e	Visit 06 (Day 17 ± 3)f	Visit 07g
Informed consent/assent	√
Demography	√
Medical/surgical history	√
Inclusion/exclusion criteria	√
IP Dispensing	√	√	√	√
Issue diary card	√	√	√	√
Physical examination	√	√	√	√	√
Vital signs	√	√	√	√	√		√
Investigator assessments for severity of diarrhea	√	√	√	√	√
Laboratory tests	√				√
Compliance check		√	√	√	√
Primary endpoints		√	√	√	√
Secondary endpoints		√	√	√	√
Concomitant medications		√	√	√	√	√	√
AE/SAE assessment		√	√	√	√	√	√

^aVisit 01 was for screening, randomization and initiation of treatment (baseline).

^bVisit 02 was second day of treatment.

^cVisit 03 was third day of treatment.

^dVisit 04 was fifth day of treatment.

^eVisit 05 was eighth day of treatment, i.e., end of treatment (EOT).

^fVisit 06 was on 17 ± 3 day and for telephonic follow up.

^gVisit 07 was unscheduled visit.