Four weeks after starting the TLC diet, subjects were
randomized in a 1:1 ratio at each site to receive either placebo
or pantethine. A blocking factor was used for randomization.
Subjects randomized to either pantethine or placebo took 1
tablet 3 times per day throughout the course of the study period
(baseline to week 16). The number of subjects included in the
research trial at each visit and the study medication taken at
each visit for subjects in the Pantesin and placebo groups is
detailed in Fig. 1. All study tablets were supplied in identical
blister packs at specified times during the investigation. Tablet
packs could only be identified by their randomization
sequence numbers. The list of identifiable sequences was
maintained in a secure, locked location by the study
coordinators. During subsequent study visits, subjects were
required to return all blister packs dispensed at the prior
session. An investigator assessed the subject's adherence to the
protocol through a review of the blister packs.