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The main efficacy analyses were carried out in SPSS Version 21 by a statistician (P.W).
Additional analyses using the three binary definitions of adherence were performed to investigate the sensitivity of the main efficacy analyses to departures from the assumed linear relationship between adherence and outcome.
The main efficacy analyses were performed 'per started cycle' (i.e. including all subjects who started treatment regardless whether they discontinued) as this provides the most conservative efficacy estimates as it also accounts for any unintended interference of premature cycle cancellations.
The trial database was maintained as blind until all data collection, checking, and cleaning for the main efficacy analyses had taken place; after this, participant condition was downloaded from the randomization service and inserted into the database.
We carried out analyses of potential subgroup or moderating variables within the same analytic framework as for our main efficacy analyses (i.e., mixed-model repeated measures ANOVAs with time as within-groups factor and condition as between-groups factor, using the SPSS MIXED command and including the stratifying variables as covariates).
After the unexpected finding that there was no difference in outcomes between the imagery and control conditions in our main efficacy analyses, we carried out further exploratory analyses to test subsequent hypotheses about why we might not have obtained the expected results.
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Primary efficacy analyses were conducted on the ITT data set.
Where possible, we intended to use intention-to-treat (ITT) data for the primary efficacy analyses.
Primary efficacy analyses were conducted using intention-to-treat population.
The sample size was based on primary efficacy analyses.
The main clinical efficacy analyses related to visual acuity are shown in Fig. 1A.
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