Randomization and masking
An experienced researcher from icddr,b, not involved in this study, prepared the randomization list using the randomization table [At the end of the study it is revealed that study group ‘B’ belongs to Fibersol-2 and study group ‘A’ belongs to placebo. Study group ‘B’, received Fibersol-2 (5 gm) dissolved in 50 ml drinking water, twice daily (suitable dose from the tolerability and acceptability trial of phase 1). Study group ‘A’, received placebo (5 gm of regular maltodextrin) dissolved in 50 ml drinking water twice daily (same dose of Fibersol-2).