A CCEPTED MANUSCRIPT
screening. After inclusion, subjects went through a two-week run-in period before baseline data
were obtained at Visit 2 with randomization being performed at the very end of visit 2.
Randomization and masking
Prior to trial conduct, the allocation of subjects in a 1:1 ratio to Bif195 or placebo intervention was
planned according to randomization lists. The randomization procedure was stratified by gender and
the lists were drawn up to n=50 for each strata using the proc plan procedure in SAS.
Randomization blocks of n=6 was used throughout and trial site and sponsor were kept blinded to
the use of randomization blocks. The randomization list and unblinding list were produced by a
third party not otherwise involved in the trial.
At screening, subjects were assigned a 4-digit screening number according to their chronological
entry into the trial. If a subject was found eligible and enrolled for trial participation, they received
MANUSCRIPT
their randomization number by blinded trial staff after all baseline assessments performed at Visit 2.
Randomization numbers included the stratification number and was allocated sequentially by trial
staff in the order in which the subjects completed Visit 2.
Test and placebo product were produced by the sponsor to be similar in smell, taste and appearance.
All trial product was packaged in identical packs with identical labelling, except for the
randomization number. All trial subjects, the clinical team, statisticians and the sponsor were all
blinded during the entire trial until database lock and signature of the request for unblinding
document.
An emergency unblinding procedure using emergency code break opaque sealed envelopes was
established to allow the investigator the option of disclosing the product assignment for any
individual subject if clinical circumstances required such unblinding. This option was not used in
the conduct of this trial. The randomization list and production of emergency code break envelopes
8
Powered by FlippingBook