Chrysant 2003.

Methods	Single‐blind, 4‐week, placebo run‐in period followed by an 8‐week randomized, double‐blind, placebo‐controlled trial conducted at 43 study centers. Analysis by intention‐to‐treat population, defined as participants who were randomized to treatment and received at least 1 dose of their assigned treatment, and had at least 1 post‐baseline ABPM measurement. ABPM was performed at baseline and at the end of the 8‐week treatment period. Only hours with at least 1 BP measurement were considered valid, and data from the entire period were rejected if there were ≥ 2 consecutive hours or ≥ 6 nonconsecutive hours with no ABPM readings
Participants	Participants (mean age 51.5 years) with mild‐to‐moderate hypertension, defined as mean seated DBP of 100‐115 mmHg during weeks 3 and 4 of placebo run‐in (with a difference of ≤ 10 mm Hg between the 2 visit means) and a mean daytime DBP of 90‐119 mmHg measured with ABPM were randomized in a 3 : 3 : 1 ratio (440 participants). 397 participants were included in the intention‐to‐treat population
Interventions	Following the placebo run‐in, olmesartan medoxomil 20 mg (188 participants), amlodipine besylate 5 mg (186 participants), or placebo (66 participants), once‐daily orally as close to 8 a.m. as possible (± 1.5 hours). Only the amlodipine 5 mg arm data and the placebo arm data were used in this review
Outcomes	Primary endpoint: change from baseline in mean 24‐hour DBP by ABPM at week 8 of treatment Secondary endpoints: change from baseline in mean 24‐hour ABPM SBP at week 8 and change in mean cuff seated DBP and cuff seated SBP at week 8
Notes	The review authors would like to thank Dr. Chrysant for providing answers to questions regarding the risk of bias assessment
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Dr. Chrysant stated that the study used interactive voice response system for randomization
Allocation concealment (selection bias)	Low risk	Central allocation with the use of interactive voice response system
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Dr. Chrysant stated this was a double‐blind study that all personnel involved with the study were blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Dr. Chrysant stated that the data gathered from the ABPM device were assessed by an independent company, and that all personnel involved with the study were blinded
Incomplete outcome data (attrition bias) All outcomes	High risk	All randomized participants were not followed to the end of the study; intention‐to‐treat population did not include all randomized participants. Only participants with study defined "valid" BP measurements included in analysis
Selective reporting (reporting bias)	Low risk	All outcomes in methods were reported
Other bias	High risk	Sponsored by Sankyo Pharma Inc.