Hermida 2005a.

Methods	prospective randomized open‐label, blinded endpoint, parallel‐group trial. 3 months of intervention Baseline similarity: age, height, weight, BMI, waist and hip perimeters, SBP, DBP,laboratory chemistry variables sample size calculation:not reported
Participants	Country: Spain Number randomised: 105,100 completed Mean age: 68.2±4.9(SD) years gender: 34 men, 66 women. Ethnicity: not reported Inclusion Criteria: untreated, age≥60years, conventional SBP between 140 and 179 mm Hg or DBP between 90 and 109 mm Hg, and ABPM diurnal mean SBP/DBP>135/85 mm Hg, or the nocturnal mean > 120/70 mm Hg. Exclusion criteria: shift workers, heavy drinkers, smokers, heavy exercisers, severe arterial or secondary arterial hypertension, nephropathy and retinopathy and/or cardiovascular disorders.
Interventions	valsartan (160mg/d) on awakening: N=53 valsartan monotherapy (160mg/d) at bedtime:N=52
Outcomes	Mortality: not reported Morbidity: not reported Blood Pressure data:24h BP change by 48h ABPM, data was obtained from graph and text (fig 5 on page 770) Adverse Events: not reported
Notes	supported in part by grants from Xunta de Galicia (PGIDIT03‐PXIB‐32201PR), and Vicerrectorado de Investigacion, University of Vigo
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	computerized random‐number generator
Allocation concealment (selection bias)	High risk	one member of the research team use of a list of random numbers
Blinding (performance bias and detection bias) All outcomes	Low risk	investigator obtaining the BP measurements and outcome assessors blinded. Benefits of the PROBE design and its validity compared with double‐blind, placebo‐controlled trials in assessing antihypertensive efficacy based on blinded ABPM measurements have been documented previously (Smith 2003)
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants were reported. 5 subjects were eliminated for second ABPM, 3 in the morning treatment and 2 in bedtime treatment.
Selective reporting (reporting bias)	High risk	Morning SBP, DBP were not reported.
Other bias	Low risk	This trial was a part of MAPEC (http://www.clinicaltrials.gov/ct2/show/NCT00295542?term=NCT00295542). "The funding body has no role in the study design, analysis and interpretation of data, writing of the reports, or the decision to submit articles to publication (Hermida 2007b)".