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The period of randomization into three arms was actually too short for a concurrent comparison.
Those who lost at least 4.54 kg (10 lb) and attended greater than 70% of the weekly WLP group sessions were eligible for randomization into one of two arms of the weight-loss maintenance phase of the trial.
Thirty-four sunderwentnderandomizationzandon, and twenty-nine complethe the protocol.
Randomization was made to two arms (omega-3 or placebo), in blocks of four individuals, stratified by centre.
Thus, randomization resulted in six arms, EFe30F, UFe30F, EFe60F, UFe60F, EMMS, and UMMS.
Patients were randomized into three study arms in two phases.
A total of 202 patients from six centres underwent randomization in the oral group between Dec 2003 and Oct 2005 1000 were randomly assigned to the low and 102 to the high group.
A total of 516 patients will be enrolled in a 1 1 randomization into the two treatment arms.
One strength of this study is that randomization into the two study arms may limit confounding effects.
Participants were randomized into one of the two arms (the intervention arm or the waitlist control arm) via a password-protected internet-based randomization program.
RESULTS: A total of 797 patients underwent randomization at 45 centers in the United States.
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