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The program began with an intensive three month phase during which participants attended two, two-hour sessions each week.
Data are collected at baseline and after each of the six month phases.
Participants were randomized either to usual care or to a 12-month intervention that consisted of: 1) weekly group participation for six months covering topics on nutrition, physical activity and lifestyle changes; 2) monthly group participation for an additional six month maintenance period; and 3) individual monthly contacts from intervention group facilitators during the second six month phase.
All the patients with positive sputum smears at the end of the initial intensive phase of treatment were given an additional month of intensive phase therapy followed by a three month continuation phase of treatment.
The third phase of the trial is a conditional three month Universal Distribution Phase in which all women enrolled in the trial would receive prophylactic oxytocin following delivery of the baby.
One of the five 6 month, phase 3 registration trials of insulin glargine [ 14] reported that the percentage of participants with an increase of three or more steps on the Early Treatment Diabetic Retinopathy Study ETDRSS) retinopathy severity scale was greater in the insulin glargine group (7.0%) than in the human NPH insulin group (2.7%).
The trial was limited to a three month data collection phase due to the wait list design, ethical constraints and restrictions on research funding.
This was a six month pilot study with a three month randomized-controlled phase (during which group A received the intervention, and group B served as controls) followed by three months of intervention in both groups.
Six month study with a three month randomized-controlled phase (group A received the intervention, group B served as controls) followed by three months of intervention in both groups.
Each of the four treatment protocols required four monthly visits to the clinic and three telephone contacts during the three month treatment/dose adjustment phase (months 1-4) in which the dose of β blocker or placebo was adjusted and behavioural migraine management was administered.
6 Study 329 was a multicentre eight week double blind randomised controlled trial (acute phase), followed by a six month continuation phase.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com