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Table 1 Variables/measures and method of analysis

From: Protocol update and statistical analysis plan for CADENCE-BZ: a randomized clinical trial to assess the efficacy of sodium benzoate as an adjunctive treatment in early psychosis

Secondary outcomes Variable/outcome

Hypothesis

Outcome measure

Method of analysis

PANSS subscales

Improvement occurred

Score [continuous]

MMRM

GAF

Score [continuous]

MMRM

CGI

Scale [categorical]: Normal–moderate (1–4) vs severe (> 5)

Generalized linear mixed model (GLMM)

HDRS

Score [continuous]

MMRM

AQoL

Score [continuous]

MMRM

PGI-I

Scale [categorical]

Chi-squared test