Pfizer588.

Study characteristics
Methods	Design: multi‐centre trial, randomised, placebo‐controlled, parallel arm, flexible‐dose, double‐blind Duration of intervention: 12 weeks Placebo run‐in: No information Post‐treatment: Not specified
Participants	Setting: Quote: “16 study sites in USA" Sample size: 190 randomised to sertraline and placebo Mean age: 37 years Sex: 49 men and 144 women, physical/sexual assault Diagnostic measure: DSM‐III‐R Inclusion criteria: Quote: “100% PTSD by DSM‐III‐R" Exclusion criteria: Quote: “CAPS‐2 score of <50 at baseline (one exception to this)" Comorbidity: No information Dropout rates: 49/190 (24/95 in the sertraline and 25/95 in the placebo group)
Interventions	Pharmacological intervention: Quote: “Sertraline ‐ Mean dose for completers 156 mg/day"
Outcomes	Outcomes: IES, DTS, CGI‐S, CGI‐I, CAPS‐2 (not clear whether primary or secondary) Time points: No information Data estimation: ITT, completer analysis
Notes	Dates of trial: Not stated Industry‐funded: No information Medication provided by industry: No information Any of the authors work for industry: No information
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	It was reported that the patients were randomised but no mention is made of the method of randomisation Quote: "Study Type: RCT"
Allocation concealment (selection bias)	Unclear risk	There was insufficient information provided to determine if study medication allocation was concealed
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	The study was described as "double‐blind", although no information was provided on which parties were blinded and how blinding was achieved Quote: "Blindness: Double blind"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	The study was described as "double‐blind", although no information was provided on blinding of outcome assessors
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	A similar proportion of participants withdrew from the sertraline group (24/95, 25%) compared to the placebo group (25/95, 26%). Reasons for withdrawals were not provided. No information was provided on whether the 2 groups differed by sample characteristics at baseline and endpoint. Data estimation for ITT and completer analysis
Selective reporting (reporting bias)	Unclear risk	The study protocol was not available for this study
Other bias	Unclear risk	No information provided to determine this