Flores 1989.

Methods	Randomization: random code assignment to 5 groups Allocation concealment: code prepared in advance, not disclosed to field team, broken at NIH laboratory after follow up ended Blinding: double (same size of ampoules given to each group). Data collection: no details Intention to treat: no Interim analysis: none Exclusion from analysis: 20\116 excluded from study for having diarrhoea, nausea, or vomiting in the week prior to vaccination. Follow‐up period: 1 week after vaccination
Participants	Age: 1 to 5 months Health status: healthy Breastfeeding: no information Immunization status: polio vaccine not given within 2 weeks of vaccination
Interventions	1. Rhesus + human (D x RRV), 10^4 PFU, single dose (n = 24) 2. Rhesus + human (DS1 x RRV), 10^4 PFU, single dose (n = 25) 3. Rhesus (RRV 3), 10^4 PFU, single dose (n = 21) 4. Rhesus + human (D x RRV + RRV), 5 x 10^3 PFU, single dose (n = 23) 5. Placebo (formula alone or with red soda), 1 ml single dose (n = 23) 400 mg citrate‐bicarbonate in 30 ml similac formula given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 1 week of vaccination
Notes	Study location: Venezuela Clinical symptoms: clinical evaluation; diarrhoea defined as ≥ 3 watery or loose stools in 24 h; severity score measured by Flores 1987 scale Laboratory studies: serology by ELISA and plaque reduction neutralization assay; stool analysis by ELISA and cultures