Amiri Nikpour 2014.

Study characteristics
Methods	Study design: RCT Study grouping: parallel group Losses to follow‐up: none Trial protocol registration: no protocol identified
Participants	Total number of participants: 46. However, 3 participants died before day 30: 1 participant in the Cerebrolysin group and 2 participants in the placebo group. 43 participants included in the final analysis. Baseline characteristics: Cerebrolysin Participants: 22 Mean age: 60 year (SD ± 9.6) Men: 12 (54.5%) Women: 10 (45.5%) Risk factor: ischaemic heart disease: 4 (18.2%); diabetes mellitus: 8 (36.4%); hypertension: 13 (59.1%); dyslipidaemia: 11 (50%); smoking: 3 (13.6%) Drug histories: beta‐blockers: 4 (18.2); ACE‐1: 3 (13.6%); angiotensin receptor blocker: 8 (36.4%); calcium channel blocker: 0 (0%); diuretic: 3 (13.6%); statin: 12 (54.5%); antidiabetic: 8 (36.4%); antidiabetic plus statin: 3 (13.6%); antidiabetic plus antihypertensive: 4 (18.2%); antihypertensive plus statin: 4 (18.2%) Stroke location: anterior circulation: 14 (63.6%); posterior circulation: 8 (36.4%) Placebo Participants: 21 Mean age: 60.1 years (SD ± 10) Men: 10 (47.6%) Women: 11 (52.4%) Risk factor: ischaemic heart disease: 3 (14.3%); diabetes mellitus: 10 (47.6%); hypertension: 13 (61.9%); dyslipidaemia: 12 (57.1%); smoking: 3 (14.3%) Drug histories: beta‐blockers: 5 (23.8%); ACE‐1: 2 (9.5%); angiotensin receptor blocker: 5 (23.8%); calcium channel blocker: 1 (4.8%); diuretic: 6 (28.6%); statin: 12 (57.1%); antidiabetic: 10 (47.6%); antidiabetic plus statin: 7 (33.3%); antidiabetic plus antihypertensive: 2 (9.5%); antihypertensive plus statin: 5 (23.8%) Stroke location: anterior circulation: 16 (76.2%); posterior circulation: 5 (23.8%) Inclusion criteria: both sexes, 18 to 85 years; focal neurological injury; ischaemic stroke within 6 to 24 hours before admission; acute focal ischaemic stroke detected by CT or MRI or both; NIHSS score of 6 to 22 at presentation Exclusion criteria: rapid improvement of signs and symptoms, or complete resolution, or both, within 24 hours; seizure upon the development of stroke; any conditions interfering with neurological examination, such as severe dementia or psychological diseases; severe heart failure; acute myocardial infarction; pregnancy or breastfeeding; significant systemic diseases associated with disability and decreased well‐being; systolic and diastolic blood pressure above 220 mmHg and 120 mmHg, respectively; CT or MRI suggesting acute or chronic haemorrhagic stroke or neoplasm, or both; hernia in the brain or increased intracranial pressure; contraindication or sensitivity to aspirin or Cerebrolysin, or both; taking other neuroprotective agents such as piracetam; and taking vasodilators such as nimodipine Pretreatment: no difference
Interventions	Cerebrolysin Frequency of dosage: intravenous injection of 30 mL of Cerebrolysin diluted in normal saline once a day for 10 days Standard treatment: 100 mg of aspirin daily Placebo Frequency of dosage: normal saline, as placebo, with a prescription order similar to the main drug Standard treatment: 100 mg of aspirin daily
Outcomes	We extracted data for all‐cause death (dichotomous outcome).
Identification	Sponsorship source: Urmia University of Medical Sciences grant Country: Iran Setting: hospital (inpatient setting) Author: Mohammad Reza Amiri‐Nikpour Institution: Seyyed‐al‐Shohada Heart Centre Email: yousefrezaei1986@gmail.com
Notes	No protocol identified.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment	Unclear risk	Quote: "In a randomised, double‐blinded, placebo‐controlled clinical trial, patients who had signs and symptoms of acute brain stroke were assessed from March 2013 to March 2014." Comment: there was insufficient information to permit a judgement of low risk or high risk, so we opted for a judgement of unclear risk
Sequence Generation	Unclear risk	Quote: "In a randomised, double‐blinded, placebo‐controlled clinical trial, patients who had signs and symptoms of acute brain stroke were assessed from March 2013 to March 2014." Comment: there was no information on allocation concealment. Added to the unavailability of study protocol, we judged this as unclear risk.
Incomplete outcome data All outcomes	Low risk	Quote: "After receiving treatments, one patient in the Cerebrolysin‐received group and two patients in the placebo‐received group died before day 30 (4.3% versus 8.7%); they were excluded from the final analysis due to lack of measuring their outcomes at 90‐day follow‐up." Comment: no losses to follow‐up. However, adverse events and causes of death were not reported, and the study protocol was not available.
Blinding of outcome assessors All outcomes	Unclear risk	Quote: "In a randomised, double‐blinded, placebo‐controlled clinical trial, patients who had signs and symptoms of acute brain stroke were assessed from March 2013 to March 2014." Comment: there was no information as to whether outcome assessors were aware of the allocated interventions. No information was provided on allocation concealment. Added to the unavailability of study protocol, we judged this as unclear risk.
Selective outcome reporting	Unclear risk	Comment: study protocol not available. Causes of death were not described; there was no information on clinically relevant outcomes.
Blinding of participants and personnel All outcomes	Unclear risk	Quote: "All patients who met inclusion criteria were randomly assigned into two groups to receive intravenously either 30 ml of Cerebrolysin diluted in normal saline once a day for 10 days (n = 23) or normal saline, as placebo, with a prescription order similar to the main drug (n = 23)." Comment: there was no information on blinding of participants and personnel. Added to the unavailability of study protocol, we judged this as unclear risk.
Other sources of bias	Unclear risk	Quote: "We thank the vice‐chancellor of research in Urmia University of Medical Sciences for providing the grant of this study. Moreover, we would like to greatly thank all members of emergency department of Imam Khomeini Hospital, Urmia, West Azerbaijan Province, Iran, for helping us in collecting the study data." Comment: there was no clear information on funding sources, and all authors declared no conflict of interest; no protocol identified