Randomization & Blinding

IWRS-style allocation · Stratified randomization · Block randomization · Emergency unblinding · DSMB reports

Subjects Randomized

84

Arm A (Active)

42

Arm B (Placebo)

42

Unblinding Events

0

Randomize Subject

Emergency Unblinding

Only authorized PI may unblind in case of SAE requiring treatment knowledge. Audit-logged.

Recent Randomizations

R001

Subject 084 (Site 02)

Age 60-69, BMI ≥30BLINDED2026-06-13 09:14

R002

Subject 083 (Site 01)

Age 50-59, BMI 25-29BLINDED2026-06-12 14:30

R003

Subject 082 (Site 03)

Age 60-69, BMI 25-29BLINDED2026-06-11 11:00

R004

Subject 081 (Site 02)

Age 50-59, BMI ≥30BLINDED2026-06-10 16:22