The mean absolute and change scores for the Roland and Morris Disability Questionnaire (RMDQ, primary outcome measure) will be analysed across all monthly time points.
The collection of bilateral anterior nasal swabs on all study children will identify viral and bacterial pathogens associated with ARI and cough at both the time of enrolment, and at monthly time points and specialist review.
The motor coordination ability of YG8sR FRDA mice was assessed on a rotarod treadmill at monthly time points from 4 12 months of age, using B6 and Y47R mice as controls.
Secondary outcome measures included changes in monthly moderate-to-severe headache days at each time point, mean monthly headache days, mean daily pain intensity, mean daily pain duration, headache-related disability scores, affective measures and quality of life scores.
More important, efficacy was assessed in a single time point, and not monthly for at least 3 months, as recommended by the IHS.
For treatment periods, data grouping consisted of delta SLO responses at baseline (time 0), during CMT (3- and 6-week time points; averaged within a person across those times), post-CMT (10-week time point), and during adjuvant monthly temozolomide (18- and 30-week time points; averaged within a person across those times).
The outgoing water from the beds was collected, and 100 ml from each time point was pooled to a monthly sample and stored at -20°C until analysis.
The trend parameter for a particular time point is chosen by a monthly specific discrete mixture between guide linear trend parameters, specific to broad period, Γ0p and Γ1p, with Γ1p < Γ0p.
In the time-series analysis, weekly data were aggregated at the monthly level (to ensure sufficient sample size at each time point).
Three monthly was chosen because a new cycle is due at this time point in both 2 and 3 weekly dosing.
