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The placebo group of the RCT phase initiated active treatment at week 16, and the active groups maintained allocated treatment and dosages until week 24.
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We maintained individuals allocated to the ControlH2O treatment in 378-L laboratory stock tubs equipped with the continuous flow of filtered and UV-sterilized water for the duration of the experiment, which is more representative of natural breeding conditions (Minckley 1972).
Treatment allocation as per the randomisation scheme was maintained by allocating study medication with the next sequential patient number.
Taken together, we proposed that while dual task could hinder balance control, postural stability may still be maintained by allocating more attentional resources to the postural task and reducing automatized control.
Participant anonymity was maintained by allocating participants an identification number and using pseudonyms for participants' names within interview transcripts.
Investigator blinding will also be maintained by allocating responsibility for this (qualitative) component of the study to one of the research team, an experienced qualitative researcher who will not be involved in quantitative data collection or analyses.
Any patients who do crossover will be analysed in the group to which they were originally allocated, maintaining an 'intention to treat' analysis.
Any patients who did cross were analyzed in the group to which they were allocated, maintaining the intention to treat approach we planned for the analysis.
Any patients who cross over from one treatment group to the other will be analysed in the group to which they were allocated, maintaining the intention to treat approach of the analysis.
Additionally, we will not withdraw patients if the study protocol was not adhered to (e.g. patient received wrong treatment arm, occurrence of protocol deviations, missed follow-up visits, etc).. Any patients who crossover will be analyzed in the group to which they were allocated, maintaining the intention to treat approach for the analysis.
This is to ensure that funds are specifically allocated and maintained for the gender sensitization training, among other training.
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