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The issues are encountered in the selection of treatments, assignment of participants and assessment of treatment preferences.
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At baseline, each patient was sequentially assigned a randomization number corresponding to treatment assignment.
Patients and assessors are blinded to the treatment assignment.
We use a potential outcomes approach to define relevant causal effects based on combinations of treatment assignment and belief about treatment assignment.
Uncertainty about treatment assignment could affect both treatment and placebo response.
Patients and those who performed the statistical analyses were blinded to the treatment assignment.
Evaluators are masked to treatment assignment to remove bias in morphologic assessment.
However, a key assumption of this approach is that of strongly ignorable treatment assignment (Rosenbaum and Rubin 1983).
The baseline data of the total cohort were used for determining the validity of treatment assignment.
Randomization of treatment assignment in experiments generates treatment groups with approximately balanced baseline covariates.
Participants are masked to diet hypotheses and all assessors are masked to treatment assignment.
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