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Table 1 Schedule of enrolment, interventions, and assessment (according to the SPIRIT guidelines)

From: Impact of phenylalanine on cognitive, cerebral, and neurometabolic parameters in adult patients with phenylketonuria (the PICO study): a randomized, placebo-controlled, crossover, noninferiority trial

  1. T0 = Recruitment, Informed Consent, Randomization; T1 = before the first treatment arm (neuropsychology, neuroimaging and blood sample assessment); T2 = after the first treatment arm (neuropsychology, neuroimaging and blood sample assessment); T3 = after the wash-out period and before the second treatment arm (neuropsychology, neuroimaging and blood sample assessment); T4 = after the second treatment arm (neuropsychology, neuroimaging and blood sample assessment); IP Investigational product
  2. *additional weekly phone-calls to assess adverse events
  3. 1Working memory, inhibition, cognitive flexibility, neural activation during working memory fMRI
  4. 2IQ, memory, fine motor speed, attention
  5. 3Voxel-based morphometry, diffusion tensor imaging, resting-state functional imaging, arterial spin labeling, magnetic resonance spectroscopy