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. 2018 Oct 18;2018(10):CD009431. doi: 10.1002/14651858.CD009431.pub3

Talley 2000.

Methods Randomised, double‐blind, placebo‐controlled trial. Multi‐centre (at least 2). Criteria for FD: equivalent symptom. with both types of FD
Participants N = 609
Female: 69%
Mean age: 46.3 years for the prokinetic group and 46.1 years for the placebo group
Countries: USA and Europe
Interventions Intervention: ABT‐229 1.25 mg, 2.5 mg, 5 mg and 10 mg twice a day
Comparator: placebo
Rescue medication: not mentioned
Duration 4 weeks
Outcomes Participant questionnaire, VAS 0‐100 used to assess severity, frequency and impact measured by 5‐graded Likert scale, duration one a 7‐graded Likert scale. Patient diary, severity of postprandial fullness, bloating, epigastric discomfort and postprandial nausea recorded on 7‐point Likert scale. Global evaluation at week 4 for excellent (complete or near complete resolution of symptoms), good (distinct improvement), moderate (some improvement), or poor (no change or deterioration). Assesed by participants.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Randomized"
Allocation concealment (selection bias) Unclear risk No information
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐bledind. Placebo was identical to active therapy.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Assessed by patient who was blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 8% (47/609) participants prematurely discontinued, the reasons were balanced between groups. The authors only reported outcome for 589 (96%) participants who had baseline data and at least one follow up assessment no more than 5 days and considered these participants as ITT population, which were 99%, 98%, 98% and 96% in active treatment but 95% in placebo group.
Selective reporting (reporting bias) Low risk Reported all pre‐defined outcomes
Other bias Unclear risk Difference in number baseline scores in table 1 and figure 2