RESULTS — A total of 383 obese men
and women met the eligibility criteria and
started the VLED treatment. Of these, 309
patients (152 men and 157 women) who
achieved 5% weight loss after 8 weeks
of VLED treatment were randomized in
the double-blind, placebo-controlled
phase of the investigation. Seventy-four
patients (19.3%) who were unable to lose
5% of their body weight during the VLED
were excluded. The randomized groups
were comparable in regard to age and
baseline anthropometric measurements
(Table 1). Mean body weight at screening
was similar in the two groups. The number
of participants with risk factors was
not different between the two groups (Table
1).