Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected and rated according to Common Terminology Criteria for Adverse Events (CTCAE) v3.0 and the relationship to protocol therapy will be rated as none, unlikely, possible or probable.
Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected in accordance with ISO14155 and the International Conference on Harmonisation (ICH) guidelines, and will be rated according to Common Terminology Criteria for Adverse Events (CTCAE) v3.0 and the relationship to protocol therapy will be rated as none, unlikely, possible or probable.
When 'Forming Coalitions' is the chosen environmental method, Persuasive Communication is rated the highest at 4.3, followed by Consciousness Raising, Goal Setting, Facilitation and Information About Other's Approval, which are all just above 4.0; Guided Practice is rated as rather unlikely at 2.7, see Table 5.
All additional AEs reported through use of the checklists or in-depth interview were rated as mild and unlikely to be related to the trial drug by trial staff; and no additional medical history or medications detected in using those methods changed eligibility for the trials.
The difference in the mean age of the two groups was rated as statistically significant, but unlikely to be of clinical significance.
Risk of bias for each domain was rated as high (seriously weakens confidence in the results), low (unlikely to seriously alter the results), or unclear.
Risk of bias for each domain will be rated as high (seriously weakens confidence in the results), unclear or low (unlikely to seriously alter the results).
Uterus didelphys was rated unlikely as no vaginal septum was visible with MRI.
