All AEs reported by the screened patients who took a NHP, consented to, and were available for, a detailed telephone interview (14%) were adjudicated fully to assess for causality.
Second, I think laughter can appear to be a very trivial, ephemeral topic to study – a unknown colleague of mine once took a pile of consent forms relating to a laughter study out of a printer at work and wrote a note on them saying: This pile of paper appears to be rubbish, based on the contents* and will be disposed of if not collected.
We did not take a written consent from the people with dementia because the intervention was focused on, and research interviews were only carried out with, the caregiver.
For those who decided to get tested, healthcare staff conducted a pre-counseling session and, after obtaining signed informed consent, took a blood sample by finger prick.
Nearly half (n=17; 34.0%) of the patients reporting an AE, while also taking a NHP, consented to be contacted for a detailed interview, of whom 7 (14.0%) were interviewed.
Participants were withdrawn if they failed to attend for follow up, withdrew consent or took a 'banned' drug i.e. all antimalarials, cotrimoxazole, doxycycline, tetracycline, chlorpheniramine and folic acid.
After taking an informed consent, pre-randomisation baseline data will be collected (see additional file 1).
After taking an informed consent, data will be collected from the eligible women through a structured closed-ended questionnaire.
After taking an informed consent and recorded CD4 date, stool samples were collected for screening of parasites.
After taking an informed consent, participants were asked orally if they had visited an ANC during their current or last pregnancy.
