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. 2018 May 9;2018(5):CD009069. doi: 10.1002/14651858.CD009069.pub3

Malaysian trial (ph3,2v).

Methods Phase IIIb, double‐blind, randomised controlled trial
Participants 271 women (135 in the vaccine arm and 136 in the placebo arm) from Malaysia
Age range: women aged 18 to 35 years
Inclusion criteria: women who were healthy
Exclusion criteria: women who had HPV vaccine, chronic use of immunosuppressants, history of allergy to vaccine compounds, history of chronic conditions of cancer and autoimmune disease, acute disease, pregnant
Interventions Vaccine: HPV16/18 AS04‐adjuvant bivalent vaccine
Placebo: aluminium hydroxide as placebo
Outcomes Safety and immunogenicity
Notes Report: Lim 2014
Last report average follow‐up time: 7 months after first dose
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Women were randomised in a 1:1 ratio with an Internet‐based centralised randomisation system
Allocation concealment (selection bias) Low risk A single treatment number was used for each patient uniquely identify the doses administered to the participant
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not described in the paper
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not described in the paper
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All outcomes (safety and immunogenicity) were reported on the total vaccinated cohort. Reason for exclusion was noted and balanced between vaccine group and placebo group
Selective reporting (reporting bias) Low risk All outcomes (safety and immunogenicity) were presented